If you’ve been following my blog, you already know I am no fan of the FDA. This bureaucracy costs drug developers so much time and money that many drugs that could save lives are never invested in and developed. I’ve talked about that here and here. This morning, the Wall Street Journal has an article about FDA staffers “helping” companies move their orphaned drugs through the process by holding workshops. The underlying story, if you read between the lines, is many drugs never make it to the market because the FDA is a road barrier that is not worth overcoming for rare diseases. The end result is people with rare diseases die or have to live with their disease with a lot less hope that a drug will be developed, all thanks to your all caring government.

Staff members at the Food and Drug Administration are doing something unusual. They are leaving Washington to help drug makers take a crucial step in developing drugs for rare diseases.

Only a statist would consider it a crucial step in the development of a drug to fill out government paperwork.

The staffers help administer the Orphan Drug Act, which provides incentives to create therapies for so-called orphan diseases—those that affect fewer than 200,000 Americans. There are about 7,000 such maladies, most of them serious, that have few or no drugs to treat them, from adenoid cystic carcinoma, a rare head and neck cancer, to Zollinger-Ellison syndrome, which is associated with a tumor that causes the production of high levels of stomach acid.

As a result, doctors may end up prescribing drugs developed for other diseases off-label, but not all insurers will cover this kind of use.

Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including seven years’ marketing exclusivity and tax breaks. Last year, just 250 requests for orphan-drug designation were filed, and 160 received it.

“We’re barely scratching the surface,” says Timothy Coté, director of the FDA’s Office of Orphan Products Development, the workshop’s sponsor. He says there are roughly 350 orphan drugs approved, covering about 150 rare diseases.

Tim Cunniff, vice president of global regulatory affairs at Lundbeck Inc., which has a number of approved orphan drugs, says most companies developing orphan drugs are small.

As I’ve stated previously, the big companies love the FDA. It’s a barrier to small companies from developing drugs to bring to market, which means less competition for Big Pharma. Small companies would develop drugs for rare diseases, because they see the whole in the market. The problem for them though is trying to find $1 billion dollars and up to 15 years time to move the drug through the FDA. This is a huge barrier to entry, and it leaves people with these rare diseases to suffer.

Big companies are starting to get more interested in rare diseases, but the key issue is the high cost of developing a drug and the typically long time it takes to move it from a lab into a clinic as a treatment that gets prescribed. Before starting down this arduous path, a company needs to feel there is a reasonable chance of making a profit.

Bing-O. Here is the proof that the FDA is a hindrance to progress. Companies have to make predictions about an extremely expensive and time consuming process, that can be swayed by politics. As we all know, everything has opportunity costs. If they decide to move forward on one drug, the money and time spent moving it through the FDA process is money and time that are not spent developing the next drug. Because of this alone, we are losing out on more drugs, but we are also making it much harder for companies to decide in favor of moving forward with a drug. It’s probably almost never going to happen for drugs for rare diseases, because the market is so small.

To help get more applications, Dr. Coté’s office put out the word: Help is available, in two workshops with on-the-spot regulatory advice. The first workshop, held last month at the Keck Graduate Institute here, drew 29 potential sponsors, from major drug companies to academic centers, small biotechs and even some patient advocates. In a follow-up survey, 74% said they had never before filed an application for orphan drug designation.

Dr. Coté said he wanted participants to understand that the workshop wasn’t providing an alternative pathway to orphan-drug designation, just regulatory advice. He said it was very important that the FDA avoid the “perception of favoritism” and even stressed that in the cover letter to an application, the sponsors shouldn’t say they had been at the workshop.

Sure wouldn’t want the “perception of favoritism”. Don’t make it easier for companies to develop drugs for rare diseases, that otherwise won’t be developed. That would be just horrible.

Barbara Fant, president and chief executive of Clinical Research Consultants Inc., attended the workshop to prepare an application for a drug-company client, and said this was her first time filing for an orphan drug designation.

An FDA staffer pointed out issues in her application that “would have come back to me as questions and delayed the designation process” if she had filed before the workshop. “I learned some nuances that I didn’t know,” said Dr. Fant, who declined to provide details about her client or the drug.

Who says you don’t have to be a rocket scientist to fill out government papers correctly. I guess being a doctor just isn’t enough. If this lady was not at this workshop, should would have probably just lost months of time before this paper went into the FDA bureaucracy and got turned down and returned, because it was missing some “nuance”.

An orphan-drug designation is no guarantee a medicine will ultimately be approved for marketing. A different FDA division reviews safety and efficacy data for approval. Upon further testing, a drug may turn out to be too dangerous or not effective. Companies may decide a product is too expensive to make, change direction, or go out of business. But Dr. Phillips and Dr. Coté hope that by increasing the pool of applicants for designation, they will increase the chances of getting more approvals.

via FDA Pushes for Cures for Rare Diseases – WSJ.com.

Did you get the underlying message of this article? Do you need more proof that the government, in this case the FDA, is a road barrier to progress? There really is no need for the FDA. There could easily be a private mechanism for testing drugs. All it would take a is change to patent laws, which have to give Big Pharma complete control of the market for a long time in order for them to make enough profit to make it worth bringing a drug to market. Because of the huge expense of the FDA, that control of the market has to be longer than it otherwise would need to be.

Also, as John pointed out in the comments section on this post, why couldn’t the FDA be optional? Why can’t we as consumers have a choice between an expensive FDA approved drug and a cheaper non-FDA approved drug? Surely, the non-FDA approved drug will go through the rigors of private testing via competitors, doctors and universities. We know the answer to that though. Government can never have something that challenges it’s claim to be our protector. If we allowed non-FDA options, the FDA would shortly be proven useless.

Don Corelone called his people in for a meeting yesterday.

WASHINGTON—The government’s top health official summoned health-insurance chief executives to the White House Thursday and told them they need to disclose more data justifying sharp premium increases.

The dressing-down, part of which was televised, was part of a campaign by the White House to build support for its health overhaul as President Barack Obama presses Congress to deliver final legislation to his desk in the next few weeks.

Health and Human Services Secretary Kathleen Sebelius called five insurance company executives, including the heads of UnitedHealth Group Inc. and WellPoint Inc., to the Roosevelt Room to request explanation on the recent rate increases.

Who is Kathleen Sebelius to summon private individuals to the white house to explain why they raised their prices? It’s none of her or Obama’s business. No one is forcing people to buy their products, so if people don’t want to pay the prices, they can choose not to. Oh yeah, they will be forced to at gun point real soon.

Mr. Obama dropped by and read them a letter from a 50-year-old cancer survivor from Ohio whose premiums rose 40% this year. He told the group that such rate increases are “unjustifiable,” White House Press Secretary Robert Gibbs said.

How about we read some letters from upstanding people that the government has imprisoned or pillaged for taxes? How about the family farm that had to be sold after gramps died, because the family couldn’t afford the death tax? How about the poor child who’s trapped in crappy public education, and because of Obama they had their charter school option taken away? Maybe we should read a letter from a child, who’s mother’s body was blown to bits by a drone attack? Oh that’s right, those aren’t American children, so they don’t matter. Maybe we should read a letter from a small business owner, who couldn’t sleep for weeks over the thought of having to layoff someone who’s become like family to him (or her)?

Insurers said the drug makers, medical-device makers, hospitals and other health-care companies are driving up the underlying cost of medical care. They said that trying to lower premiums without addressing those costs was destined to fail.

“The rate is really reflective of our other parts of the health-care delivery system,” Ron Williams, chief executive of Aetna Inc., told the group at the beginning of the meeting. In an interview after the meeting, Mr. Williams said the secretary should have included representatives from those industries.

I can see it now. “Please Mr. Obama. It’s not our fault. Please don’t point the gun at us.” Truly I think the insurance companies are the root problem of health care costs, but it’s not their doing. We have decided that insurance is supposed to cover everything, and then we complain when prices skyrocket and premiums skyrocket. Government of course played started it all off with their wage caps, HMOs, mandatory coverage, tax credits to businesses for supplying insurance, medicare/medicaide, etc.

The day started with gracious exchanges followed by sharper words afterwards

Ms. Sebelius asked the companies to begin posting information online for consumers to explain how much of their revenue goes toward administrative costs, marketing and actual care, along with other details of the rate increases. She called for “greatly increased transparency about what indeed is going on.”

This could make a great movie you know? Kathleen Sebelius can be walking around the room, nonchalantly waving a gun around as she’s talking. Not really pointing it at anyone directly, but they get the point. Then she says, “OK, I’ll tell you what. (Need mob sounding accent) Here’s what I want you to do. I want you to start posting all your information online.”

Insurance company: “But that information is confidential. We already are forced to disclose financial information for the SEC. That would give too much info to our ….”

Sebelius cocking the gun and turning towards the complaining insurance executive: “I think I’m being fair here. Now, are you going to do like I ask or what?” She stares down the executive, who meekly gives a nod.

Several executives at the meeting said they didn’t immediately commit to posting the information but were open to the idea. Much of that data is already detailed in filings to state insurance regulators, though they are difficult to access. Publicly traded companies report executive compensation and national cost trends, but keep some other measures under wraps as trade secrets. “There might be more transparency out there than you might realize,” said UnitedHealth Chief Executive Stephen Hemsley.

The two sides couldn’t agree whether insurers are highly profitable or just scraping by. Industry executives rolled out data showing their average profit margin was 2.2% last year, lower than other health industries. Ms. Sebelius cited figures showing that top insurers earned a collective $12 billion in profits last year, a 56% increase from the prior year, but that didn’t account for one-time gains.

Oh my world. You mean these companies are actually trying to make money by providing a service to customers? The audacity (and not of hope). How much does the Obama administration think these guys are going to make once Sebelius and Obama turn the gun on the people and force us to become customers? At that point, the government controls both citizen and the company, so who knows really. A 2.2% profit margin is nothing to write home about. Also, considering that health care is 1/6th of our economy, earning a collective $12 billion is not a lot of money. Think about the collective money Obama and the rest of government throw around.

The health overhaul, if passed, would require most Americans to carry health coverage or face a fine, meaning insurers would get more business.

Ah Ha! That will show those evil corporations! Wait….. wait… did I miss something?

However, insurers would be required to accept all applicants, including those who are sick. And they would see tougher restrictions on premium increases, particularly through the new state-based insurance exchanges.

Doesn’t state-based insurance exchanges sound so free market? This is sort of like the guy who comes to have a meeting with Don Corleone, so he can ask to do business in the neighborhood. Of course the Don is a reasonable man. He’s not going to be unfair. The new guy can do business. He just has to pay the toll to the mob…..I mean the government.

The White House has also proposed a new federal body with power to review premium increases. But that may not end up in a final bill due to procedural regulations that might require it to be jettisoned. That would be a relief for insurance companies, who say the panel would duplicate the rate regulation they already get from individual states. “If you have the rules written in the states and the prices written in Washington, there might be a disconnect,” said Angela F. Braly, chief executive of WellPoint Inc.

via Health Secretary Sebelius Debates Rate Increases With Insurers – WSJ.com.

Don’t forget though. All this additional regulation, bureacracy, panels, etc is going to lower cost. Obama said so.

Some drug company must not like Cheerios eating into their cholesterol drug sales. The FDA better get involved.

Last year the Food and Drug Administration made itself fodder for late-night comedy when it warned the manufacturer of Cheerios against boasting about some of the cereal’s health benefits. “We have determined [Cheerios] is promoted for conditions that cause it to be a drug,” the FDA said in a letter to General Mills.

By this logic, consumers would need a prescription to buy a box of the oats.

The letter typifies the FDA’s longstanding discomfort with health claims made on food labels, particularly those touting the medical benefits of certain diets and ingredients.

via Scott Gottlieb: The FDA Takes on Cheerios – WSJ.com.

This is a perfect example of how we have all been brainwashed. Everyone just assumes that the FDA really has a clue what they are doing and that they really our there to protect us.

Would it be surprising to see Big Pharma using the FDA to go after companies that might eat into their drug sales? Who wouldn’t love eating Cheerios instead of taking cholesterol medicine?

Also, why don’t people ask how many people die as a result of the FDA’s involvement in drug testing. It takes almost $1 billion and up to 15 years for a drug to make it through the obstacle course laid out by the FDA. No wonder drugs are so expensive. So, how many people die because of the time lag of getting a drug to market? Also, how many drugs that could save peoples lives just can’t make enough profit to justify running it through this expensive, time consuming process?

Has anyone thought maybe the FDA and this expensive process was put into place to protect Big Pharma from small competitors? Like most government regulations, only the huge corporations can afford to play the game, so they love all the regulations. It prevents the up and comers from ever nipping at their toes.

Quit assuming the government is their to protect you. The FDA is not about protection. It is about control. As long as the government controls this part of society by deciding who can play, they maintain the power. They pick the winners and losers, and they are the ones who need bribed, elected, and need to remain in power.

During the Health Care Summit yesterday, the word pooling was used a lot. Typically, it was in reference to how the government can enabled people and small businesses to setup pools to purchase health insurance. Has anyone asked what is preventing that now? The politicians act like nature itself is preventing “pooling”.

Senator Baucus: So the main point is we’re not really that far apart. We’re trying to find ways for small business to pool, small business to take advantage of competition, they shop and compare; and also some tax provisions that enable — to encourage businesses to get health insurance.

Congressman Andrews: And then the President asked the question about whether we can find agreement on pooling the purchasing power of small businesses and individuals so they can get the same deal that big companies and members of Congress get. And my friend John Kline talked about the association health plan proposal. Respectfully, John, I think that what you’re talking about with association health plans and what we’re talking about with exchanges is a semantic difference. It’s a matter of pooling the purchasing power of small businesses and individuals to get a better deal.

President Obama: I just want to point out, though, that the principle of pooling is at the center of both the Senate and the House bill.

Representative Boustany: Small business health plans is one way to really deal with this and allow for pooling.

What is preventing people and small businesses from pooling? It’s the same root problem of all our problems, GOVERNMENT. The government is the one who sets up these tyrannical rules and regulations that say what “free” people can and can’t do. They tell you how you are going to buy, what you are going to buy, how you are going to pay for it, and on and on. It is not nature, and it is not the free market.

If these geniuses want to enable people to pool, they should get the government out of health care. If pooling makes sense for people, they will do it themselves. The problem is right now they can’t because government is a pool of bad regulations and idiots with bad ideas.

Yesterday, Obama held his health care summit with both parties. While working, I had it playing in the background. Unfortunately, I found my self laughing and yelling at the TV more often than I’d like to admit.

What the summit highlighted to me is the complete ignorance of Obama when it comes to economics. He can bring out his laundry list of sob stories, but it still doesn’t change the fundamental economics that I outlined in a previous post on root causes.

Here is a sample of Obama’s ignorance.

Tom Coburn:

“So when you break down the costs, what we know is 33 percent of the costs in health care shouldn’t be there.

And how do we go about doing that? And what are the components of that cost? And when you look at, when it’s studied, if you look at what Malcolm Sparrow from Harvard says, he says 20 percent of the cost of federal government health care is fraud. That’s his number.

If you look at Thomson Reuters, when they look at all of this, they say at least 15 percent of government-run health care is fraud.

Well, when you look at the total amount of health care that’s government run, you know, you’re talking $150 billion a year.

So tomorrow, if we got together and fixed fraud, we could cut health care 7.5 percent tomorrow for people in this country.”

“So it seems to me if cost is the number one thing that’s keeping people from getting care, then the efforts of us, as we go after cost, ought to be to go to those areas where the cost is wasted.

And there’s a philosophical difference in how we do that. One wants more government-centered approach to that. I would personally prefer a more patient-centered, market-orient approach to that. But nevertheless, there’s where we can come together, just on those two areas, where we could cut costs 15 percent tomorrow. And that’s for everybody in the country.

What would — what would happen to access in this country if tomorrow everybody’s health care costs went down 15 percent? Access would markedly increase.”

Obama:

“So that’s an example of where we agree. We want to eliminate fraud and abuse within the government systems.

Let’s recognize, though, that those savings in the government systems, which will help taxpayers and allow us to do more, doesn’t account for the rising costs in the private marketplace.”

via Sen. Tom Coburn discusses cost containment at the White House health summit – washingtonpost.com.

Can you believe how ignorant Obama is about markets and the economy? I guess based on his performance so far, you are probably can.  Coburn explains that based on the best case numbers 15% of all government spending is waste. The government accounts for 50% of all heath care spending already, so that 15% would count for 7.5% of all health care spending. Obama seems to think that there are two separate and unrelated markets and says that explains rising government costs but not the private sector costs. WHAT? Are you serious Mr. President?

This would be like dividing up a bathtub into half private and half government with the faucet on the governments side. When the tub starts overflowing, Obama would say, “Well the faucet explains why the government side is overflowing, but that doesn’t explain why the private side is as well.”

There is one health care market. It doesn’t matter where the money comes from. If more money is thrown at the same resources, prices go up. What Coburn is saying is you have 15% of all the government’s money as waste thrown into the market which is chasing the same resources as the private sector. That is one of the reasons costs are going up on both sides.

This one statement should highlight why government involvement in anything is a complete disaster. They have absolutely no concept of economics or reality for that matter. Democrats want to legislate based on feelings and wishes. Well, I may wish everyone was a millionaire, but that doesn’t mean it’s good policy. It doesn’t matter how many stories I tell about poor people.

You seriously have to laugh at the idiocy of our government officials. They simultaneously do things that drive up costs at the same time they try to cap costs. It’s like trying to squeeze the air out of one end of a balloon at the same time trying to keep it from going to the other end.

Seeking to revive his stalled health-care legislation, President Barack Obama is proposing a new idea to address health costs, giving the federal government authority to block insurers from making premium rate increases.

Sorry, one second. I’ll be right back…………

Ok, I didn’t think so. I was looking to see where in the Constitution it says the Federal government has any power to block private enterprises from raising their prices. Competition will prevent private enterprise from raising their prices above market prices. Oh, that’s right our government prevents competition between states.

The move raises the ante after two weeks of presidential bashing of rate increases including WellPoint Inc.’s decision to raise premiums for some California customers by as much as 39%. WellPoint has defended its price increase as unavoidable in light of rising health costs.

While I would hate to sound like a conspiracy nut, this huge rate hike sure comes at an opportune time for ObamaCare. I mean, if I wanted to help out Obama, I would probably do just this. This would make people just mad enough to say “Screw it. Let the government take over the industry. How can they justify a 39% increase.”

Meanwhile, once the health care theft bill is passed, the insurance companies have a huge increase of new customers who have no choice but to buy their crappy products. After all, the customers has a gun pointed at them.

Private insurance companies are now regulated by the states, which review proposed rate increases. Under the Obama proposal, the federal Department of Health and Human Services would gain the power to review and block premium increases.

via Obama in New Health Push to Block Insurers From Raising Premiums – WSJ.com.

Wow, I didn’t realize there was no federal regulation of the insurance industry. The Wall Street Journal really did break news this morning. Can we confirm this and burn all the papers in the federal registry?

States, like the rest of our government idiots, do tell insurance companies they have to provide coverage for all kinds of medical conditions even when the customer doesn’t want or need it. This does not help consumer. They are not getting something for nothing just because state governments tell insurance companies they have to provide certain coverages. The customer still has to pay for services they never wanted and do not need.

Then in order to make sure the citizen can’t avoid the idiotic ideas of their local states, the federal government steps in and makes sure you are trapped. They make sure you cannot buy insurance from across state lines. This is no different than how they trap us into the expensive drug market we have here in the US. Because we aren’t allowed to buy drugs from across the border, drug companies can charge whatever they want.

After all this anti-free market, anti-consumer, anti-freedom idiocy is put into place, you get demagogues like Obama saying the free market has failed. He must step in. The government must have the power to take over the private sector in order to save us. Meanwhile, the only saving we need is from our fascist government.

Nick Gillespie was on Stossel and got into a heated exchange with a lady who thinks she knows how to live your life better than you do. Underlying her entire argument is that you do not have the right to choose what to eat or what is best for you. You gave up that right when our government decided they had a role in our health care system. While food is the main focus, if we have socialized health care for all, this will spread into every aspect of our lives.

YouTube – Nick Gillespie pwns Blond Health Nazi.

A buddy of mine sent this to me. This is very bad if this passes. Government will have real time access to your finances, be able to take money out of your bank account at any time, and on and on. You will not be anywhere near a free citizen if this passes, not that you are now.

YouTube – Know the TRUTH about the Government Health Care Bill H.R.3200 – Key Points.

One of my favorite quotes from Ben Franklin is, paraphrasing, “People willing to trade their freedom for temporary security deserve neither and will lose both”. Not only does it apply to us giving up our liberties for security from terrorism, foreign nations, or even the local drug dealer. It can also apply to economics. It could easily be…

“People willing to trade their economic freedom for temporary economic stability deserve neither and will have neither.”

Think about it. We have handed over our economic liberty to the Federal Reserve, who is supposed to prevent the business cycle and inflation. How’s that working out? We’ve lost 30% of our spending power just this past decade and had the biggest economic crisis since the great depression. Since the inception of the Fed, the dollar has lost 98.3% versus gold.

We’ve handed over 12.4% our income to the government for social “security” in hopes that we’ll have a decent retirement. As everyone knows, it is bankrupt, already been spent, and for those already on it, it sure does not provide any quality retirement.

Now the government is going to force us to buy health insurance and steal money from some of us to pay for health insurance for others, so that we don’t go bankrupt when we are sick. To provide the economic stability of knowing you have health insurance coverage, we’re giving up the economic freedom to make the best financial decision for ourselves. While it is not enacted yet, I’m sure the same principle will apply. If it works like the UK’s health system, everyone will still have to buy private insurance if they want to see a doctor in this life time. Doctors will be restricted in what they can offer, leading some to travel over seas for restricted procedures. We’ll still be locked into the closed drug market that prevents us from buying drugs outside our borders. All of this will lead to an economic disaster down the road and a massive economic collapse.

In the end, we never get what is promised in exchange for our freedom. We’ve given up our liberty, and as Ben Franklin said, we’ve got neither security nor economic stability.

During the election, not only did Obama promise to air the health care negotiations on C-SPAN, but he also promised he would pass drug re-importation. As of right now, the health care reform bill explicitly prohibits drug importation as a bribe to the drug companies.

Do you really think the government cares about your health care and how much it costs? Of course they don’t. They only care about control. Drug importation is just another example. Why do you think the drug companies are running to the rescue of the Democrat in Massachusetts?

In a free market, goods and services are not restricted by where they can be purchased or sold, but with government force, drugs cannot be purchased from outside our borders. Why is that? Is it really because the government wants to protect us? Aren’t the Democrats always telling us we need to be more like Europe and Canada? Then they say we can’t trust importing drugs from those nations. The truth is they are closing the market off to us. They want us trapped in this government backed market. This is not the free market.

If we were allowed to import drugs, drug companies would not be able to pillage the American people. The only reason they are able to is because of the gun in the room. The gun is the government, and it is there to threaten you if you don’t buy the more expensive drugs. After all, they promised the drug companies if they do what they’re told, they would protect them. Don Corleone would be so proud.

Yet, we are told the free market can’t provide affordable medical care. This same thing takes place on the state level with health insurance. So, what would the free market really look like without government coercion again the people? Well, Americans would import the cheaper drugs. Drug companies would see the that game is up via lost profits in the US. They would then start stabilizing prices around the world, which would lower the US prices. Drugs are a good, and a good should cost no different in one part of the world as another except for distribution and currency exchange costs.

Can you imagine if Americans were told you can’t import your oil. You have to buy oil from within the US, and the oil company can charge a different price in the US than it charges elsewhere? How much do you think gas would cost?

Isn’t it time everyone starts waking up that we don’t live in a free market. We live under a fascist government. There is no part of our economy where the government isn’t using is monopoly on force to pick winners and losers, to force citizens into giving their money to corporations, or where inefficient companies have to compete to survive against the up and coming little guy.