Branco cartoon via Liberty Alliance
One of the negatives of a developing civilization is that with it comes more and more rules, regulations, costs, much of it driven by a culture of litigious complainers, ill-informed reporters, bloated bureaucracy, political hacks and ultimately a desire by people to legislate morality.
We could have cures for diseases but bureaucracy stands in the way. The government makes it so expensive to come up with drugs and vaccines that only mega-corporations can design them and they will only do so if they can make money by doing it.
ObamaCare and the FDA are making matters worse, not better. ObamaCare is a massive, inefficient redistribution of wealth and healthcare services and the FDA is stomping on medical progress. Then there are the drug companies but before curtailing profits and increasing controls on drug companies, the bureaucracy and culture of the FDA need a complete overhaul.
Millions have died from Ebola and there is a cure around the corner, the most famous being ZMapp. We could possibly wipe it out but the FDA has stood in the way. It was cost-ineffective to produce it.
Cancer is the same. Avastin was keeping cancer patients alive but it costs too much, the government won’t fund it, and the companies won’t make it.
The astronomical increase in costs of some generic drugs provides a good example of government gone wrong.
Generic drug prices are skyrocketing under ObamaCare.
According to a National Jounal report back in January, “pharmacists were faced with triple- or quadruple-digit percent increases in drug costs, potentially devastating to their businesses”.
It’s not the pharmacies raising prices, the report asserted. Pharmacists were as stunned as everyone else.
The prices have continued to worsen since then.This past month has been particularly alarming according to some medical professionals we’ve spoken to because the sudden increases continue wildly unabated.
People are coming into the clinics and doctors’ offices here on Long Island – poor, working class, seniors – with bills of $400, $900, $1000 for their monthly prescriptions for generics in the past month alone. They can’t afford it.
Drug companies have a role in this.
Big Pharma wrote the pharmaceutical section of ObamaCare and they can charge whatever they want.
It was the deal Democrats made with the pharmaceutical companies to get ObamaCare passed. My Democratic Congressman Tim Bishop said the drug companies wrote that section of ObamaCare but he didn’t approve of it. Yet, he still voted for it. Every Democrat voted for it.
Prior to ObamaCare, generic prices only went in one direction and that was down.
It’s not every drug, but it’s many vital drugs that are affected.
Digoxin, an important heart medication, has gone up almost 10 times the cost since August.
Whole ranges of generics have soared 10-fold in the past year.
Doxycycline, an antibiotic used to treat conditions including Malaria and Lyme disease, a very important medication here on Long Island, kicked off the trend in November 2012. Doxycycline spiked upwards of 1,000 percent in 2013, according to a survey by the National Community Pharmacists Association.
Doxycycline supposedly experienced a manufacturing problem and had a temporary shortage because of the increased demand.
Some drugs have increased in price as much as 6,000 percent and these are common, formerly low-cost drugs.
Drug companies say the prices are necessary because it costs a billion dollars to bring a new drug to market – they have no choice. Many of the profits go into R & D to bring new drugs to market, they say.
Thanks to government regulations, many passed under this administration, it does cost a billion dollars to bring a new drug to market. It only costs $100,000 to start up a new tech company. That too will change once the government gets involved with them.
In the meantime, expect more of our innovators to go into technology fields. We can’t expect to see startups if it costs a billion dollars. Unfortunately startups are where much of the innovation comes from – new startups are not burdened by as many restrictions.
The big government that helped bring these increases about will most likely step in and make the situation worse by intervening in the market and imposing price controls instead of doing anything about the oppressive regulations.
That doesn’t exonerate drug companies, but the problem goes so far beyond them.
The FDA is keeping drugs from getting to the market. There are drugs that can cure some types of cancer, Ebola and other serious diseases that kill millions each year, but the government regulations, paperwork and obsession with not harming one person has led to a bureaucratic brick wall.
The FDA has refused to allow two forms of the generics for the drug Copaxone on the market. It’s used to treat MS and is badly needed. There is no valid reason for the denial.
The FDA’s inefficient regulatory morass translates into delays of new drugs and generics ready for market. The average length of time for a new drug to come to market is ten years. What is the drug company supposed to do in the meantime? Exist on air? They have to make up the loss.
One reason the FDA is failing is because they don’t receive accolades for approving breakthroughs but they do suffer public rebuke if even one person dies because of a misused drug.
We are sending the FDA the wrong message and that message is led by a minority of people.
Drug- and device-development times actually increased more than 70 percent over the past decade because the FDA keeps demanding more studies and more data using outdated techniques. Paperwork is killing innovation.
Another serious problem is the FDA relies on dated science.
The FDA recently went after and destroyed a google-backed company called 23andMe for providing clients their own genetic information gleaned from the client’s DNA swab. The reason? The government decided that people might not be able to handle the information about their own DNA properly.
Only the government can have our genetic health information apparently.
The FDA’s insistence on using a one-size-fits-all model in the genomics industry will continue to limit success in developing medical interventions and drug development. The potential for genomics in curing hereditary diseases is unlimited were it not for the FDA.
“The search for one-dimensional, very simple correlations—one drug, one clinical effect in all patients—is horrendously obsolete,” says Peter Huber, senior fellow at the Manhattan Institute.
Scientists today have the technology to tailor treatments to an individual’s unique genetic code, but the FDA’s outdated “one-size-fits-all” drug approval model is blocking innovation.
From an interview with Peter Huber by Reason Magazine:
Regulatory processes within the FDA are choking pharmaceutical efforts to bring the benefits of personal genomics directly to patients, Huber contends. Pharmaceutical companies are very good at designing targeted drugs. The technology—and talent—exists to tease out complex patterns from the enormous amount of molecular and clinical data needed to develop those drugs.
However, the FDA does not have the expertise nor the resources that are found among companies like Google or Microsoft, which regularly work with big data. The FDA is still locked into the traditional model of ‘one drug, one clinical effect for all patients.’ Diseases are not ‘one cause, one effect,’ says Huber, and “if you demand that drugs perform that way, we will not cure many of the serious diseases we’re now facing.”
People who like ObamaCare want to take the profit out of healthcare but they are missing one important point. We have the best healthcare and we have the best drugs because of competition and profit which encourages the best and brightest to invest the time and energy necessary to make all this innovation happen. It doesn’t always work and there is a place for government regulation but they have overreached.
The reason we have drugs for erectile dysfunction but not Ebola is because there is financial incentive for one and not for the other. People who want drug companies to work for charity’s sake will find them unwilling. What people should concentrate on is one serious underlying cause – expensive government regulations.
There is one diagnostic startup called Nanobiosym that has a small device that can accurately detect Ebola and other infectious diseases in less than an hour. Two other companies can create vaccines for the flu and other diseases and they could have an Ebola vaccine tomorrow but the FDA insists on randomized studies and they make endless demands for more data.
It ends up costing millions and drains these smaller companies of funds and incentives.
It’s not worth trying for many of these companies because they will go bankrupt before it gets to market. Then they will probably have the government tell them what they are allowed to charge. That’s where all this is headed.
Asked why there is no Ebola vaccine, National Institutes of Health Director Francis Collins claimed we’d have one if not for NIH budget cuts. That’s not accurate.
The truth, according to a report by the NY Post, is that “NIH funding for infectious diseases has doubled since 2001. But in 13 years, it developed three (ineffective) vaccines.”
Nobel Laureate microbiologist Joshua Lederberg noted, “The single biggest threat to man’s continued dominance on the planet is a virus.” The second-biggest threat: a federal culture that rewards the delay of medical progress.
The more regulations and controls the government puts in place, the less innovation we will see.
Some drug companies claim there are shortages and that’s why some generic drugs are going up in price but, the truth is they are making the same drugs in other milligrams and charging much less.
Some of the problem might be attributable to shortages because ObamaCare requires all health insurance plans in the exchanges to cover prescription drugs. The new health reform law appears to be increasing the demand for drugs and creating shortages, causing prices for generic medications to rise even higher in the future.
In any case, government intervention in the form of ObamaCare has made matters worse and will continue to make them worse as they lay down more regulations. It’s a 2,000+ page bill with 10,000 pages of rules. How could anyone think that would work?
In the case of many diseases, it appears that true cost control will remain elusive as long as the available therapies can only manage the symptoms and progression of the disease, rather than cure it. If the current market dynamic continues, that just means more patients will be using newer, more expensive drugs but they won’t be cured.
As long as drugs are to ease symptoms and not cure diseases, higher costs will be a fact of life.
The government’s solution is more government and one that can ration indirectly.
One such solution is the IPAB. The Independent Payment Advisory Board will consist of 15 people who may or may not be medical professionals and who will be appointed by the president. They will act mostly outside of congressional oversight. Their job, which begins in January, will be to keep Medicare costs down by mandating prices charged by doctors and hospitals using a one-size-fits-all approach. This again does not get to the root of the problems and creates new problems.
There is a similar mechanism for non-Medicare patients.
If you like your big government, you can keep it but you might not be able to live with it.