More FDA corruption and big pHarma whinning

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For years I’ve been talking about the corruption of government agencies and their allegiance to the pharmaceutical industry. Now, we have a CEO of Imprimis Pharmceuticals, Inc. whining about it because it’s taking profit away from his company. So, Mark L. Baum, the CEO of the company writes an article entitled “How FDA Rules Made a $15 Drug Cost $400” to stop competition from overwhelming his company.

Before depicting his article that appeared in the Wall Street Journal on April 6, 2017, let me ask a question: How come the big food companies, the dairy industry, the meat, fish and poultry industries, the egg industry, the processed food industry, the medical profession, and big pHarma don’t tell anyone that eating a plant-based diet and taking organic sulfur crystals (sulfur used to be in the soil until the Rockefellers convinced the farmers to give up on manure and switch to petro-chemical fertilizers killing all the essential mineral sulfur in the soil) will reverse just about every illness and disease

The answer is simple: Profit!

OK, here we go with Baum’s article”

“The theory is that generic drugs should be less expensive than the original. By the time a generic hits the market, the drug’s patent has expired, allowing competition from companies that didn’t spend millions of dollars to develop it. As more options become available, prices are supposed to drop. But, because of quirks in America’s regulatory system, it doesn’t always work out that way.

In 2009 the FDA (Fraud and Drug Administration) approved a new version of Colchicine, which treats symptoms of gout ( but hey, why encourage anyone to put a lot of fiber in their diets that would push out the accumulated crap build-up in the arteries and eliminate the gout problem?). Prices rose from 25 cents to $6 per pill. Two years later, the agency approved a new hydroxyprogesterone, which helps premature births (stemming from alcohol abuse, street drugs, high blood pressure, bloating disorders, infections, etc. Gee, would diet have anything to do with that?). It went from $15 to $400 an injection.

What explains the counterintuitive price increases? All these prescription drugs fall under a category known as DESI drugs, named for their inclusion in an FDA program called Drug Efficacy Study Implementation. These drugs came to market before 1962, when the FDA approval for a drug required proving its safety but not its efficacy. Such drugs, manufactured under expired patents, are used by millions of Americans today.

But once the FDA approves a new drug application for a DESI drug, the existing drug can be pulled from the market. The “new” is treated as a material advance because it underwent testing for safety and efficacy, even though the DESI version was proved safe and effective over decades of actual use. The developer of the new drug may also get a new period of market exclusivity that lasts three years.

This makes little sense. Market exclusivity should let pharmaceutical companies recoup their often enormous investments in genuinely new drugs (In God we trust, all others pay cash!). Giving monopoly protection for what is essentially a generic version of a DESI drug merely enriches sharp-dealing companies while injuring patients (and we all know that synthetic chemicals are great for the body. LOL!)

Another reason generics often face no competition was described by Scott Gottlieb< President Trump’s nominee for FDA commissioner, in these (Wall Street Journal) pages last year. He noted that a generic-drug application can cost as much as $15 million. This high upfront cost is part of why would-be manufacturers of generics often pass on the opportunity to compete against branded drugs with smaller markets. This has allowed many pharmaceutical companies to raise priced with impunity (if you think I’m gonna give up my homes in Rumson, NJ and Beverly Hills, CA, think again).

Overhauling the drug-approval process will take time. But there are already tools to help insure reasonable prices for the estimated 17% of U.S. drugs that lack competition.

The Drug Quality and Security Act of 2013 was designed to ensure that companies can quickly respond to a drug shortage by allowing a new type of drug maker, called an “outsourcing facility”, to enter the market. It copies an FDA-approved product, regardless of exclusivity, provided that it manufactures the drug in an FDA-registered and inspected facility using FDA-approved ingredients (you know, like MSG, GMOs and glyphosate). American companies, including mine, have invested in such facilities (as well inundating TV advertising)

Yet the potential of this legislation remains untapped. The FDA should clearly define “drug shortage” to include a lack of access due to abnormally high prices. With this simple change, FDA-registered outsourcing facilities could quickly bring sky-high prices for monopoly generics with expired patents back to earth.

At the same time, the Trump administration should authorize Medicare and Medicaid to pay for compounded drugs made in outsourcing facilities, which currently aren’t covered (and then pass those costs on to the seniors and reduce their social security benefits). Right now government policy forced Medicare to pay Turing Pharmaceuticals, the brainchild of the notorious “pharma bro” Martin Shkreli $750 for a single Daraprim pill (why couldn’t it be me?). Instead, Medicare should be able to choose my Daraprim alternative, priced at 99 cents a pill, which has been safely dispensed to thousands of patients nationwide (Daraprim treats parasitic infections, which come from mostly a flesh-based diet).

Reforming the drug-approval process is critical. Meanwhile, these steps would ensure that demonstrably safe drugs (like mine) can be offered at a reasonable price to patients who need them. If drugs must carry a high price tag, it should be to recoup the investment in innovation, not to enrich a monopolist for an off-patent, inexpensive medicine it did not develop in the first place (competition should be banned)”.

And life goes on!

Aloha!

Sources:
www.asanediet.com
www.webmed.com
www.daraprimdirect.com

Hesh Goldstein
When I was a kid, if I were told that I'd be writing a book about diet and nutrition when I was older, let alone having been doing a health related radio show for over 36 years, I would've thought that whoever told me that was out of their mind. Living in Newark, New Jersey, my parents and I consumed anything and everything that had a face or a mother except for dead, rotting, pig bodies, although we did eat bacon (as if all the other decomposing flesh bodies were somehow miraculously clean). Going through high school and college it was no different. In fact, my dietary change did not come until I was in my 30's.

Just to put things in perspective, after I graduated from Weequahic High School and before going to Seton Hall University, I had a part-time job working for a butcher. I was the delivery guy and occasionally had to go to the slaughterhouse to pick up products for the store. Needless to say, I had no consciousness nor awareness, as change never came then despite the horrors I witnessed on an almost daily basis.

After graduating with a degree in accounting from Seton Hall, I eventually got married and moved to a town called Livingston. Livingston was basically a yuppie community where everyone was judged by the neighborhood they lived in and their income. To say it was a "plastic" community would be an understatement.

Livingston and the shallowness finally got to me. I told my wife I was fed up and wanted to move. She made it clear she had to be near her friends and New York City. I finally got my act together and split for Colorado.

I was living with a lady in Aspen at the end of 1974, when one day she said, " let's become vegetarians". I have no idea what possessed me to say it, but I said, "okay"! At that point I went to the freezer and took out about $100 worth of frozen, dead body parts and gave them to a welfare mother who lived behind us. Well, everything was great for about a week or so, and then the chick split with another guy.

So here I was, a vegetarian for a couple weeks, not really knowing what to do, how to cook, or basically how to prepare anything. For about a month, I was getting by on carrot sticks, celery sticks, and yogurt. Fortunately, when I went vegan in 1990, it was a simple and natural progression. Anyway, as I walked around Aspen town, I noticed a little vegetarian restaurant called, "The Little Kitchen".

Let me back up just a little bit. It was April of 1975, the snow was melting and the runoff of Ajax Mountain filled the streets full of knee-deep mud. Now, Aspen was great to ski in, but was a bummer to walk in when the snow was melting.

I was ready to call it quits and I needed a warmer place. I'll elaborate on that in a minute.

But right now, back to "The Little Kitchen". Knowing that I was going to leave Aspen and basically a new vegetarian, I needed help. So, I cruised into the restaurant and told them my plight and asked them if they would teach me how to cook. I told them in return I would wash dishes and empty their trash. They then asked me what I did for a living and I told them I was an accountant.

The owner said to me, "Let's make a deal. You do our tax return and we'll feed you as well". So for the next couple of weeks I was doing their tax return, washing their dishes, emptying the trash, and learning as much as I could.

But, like I said, the mud was getting to me. So I picked up a travel book written by a guy named Foder. The name of the book was, "Hawaii". Looking through the book I noticed that in Lahaina, on Maui, there was a little vegetarian restaurant called," Mr. Natural's". I decided right then and there that I would go to Lahaina and work at "Mr. Natural's." To make a long story short, that's exactly what happened.

So, I'm working at "Mr. Natural's" and learning everything I can about my new dietary lifestyle - it was great. Every afternoon we would close for lunch at about 1 PM and go to the Sheraton Hotel in Ka'anapali and play volleyball, while somebody stayed behind to prepare dinner.

Since I was the new guy, and didn't really know how to cook, I never thought that I would be asked to stay behind to cook dinner. Well, one afternoon, that's exactly what happened; it was my turn. That posed a problem for me because I was at the point where I finally knew how to boil water.

I was desperate, clueless and basically up the creek without a paddle. Fortunately, there was a friend of mine sitting in the gazebo at the restaurant and I asked him if he knew how to cook. He said the only thing he knew how to cook was enchiladas. He said that his enchiladas were bean-less and dairy-less. I told him that I had no idea what an enchilada was or what he was talking about, but I needed him to show me because it was my turn to do the evening meal.

Well, the guys came back from playing volleyball and I'm asked what was for dinner. I told them enchiladas; the owner wasn't thrilled. I told him that mine were bean-less and dairy-less. When he tried the enchilada he said it was incredible. Being the humble guy that I was, I smiled and said, "You expected anything less"? It apparently was so good that it was the only item on the menu that we served twice a week. In fact, after about a week, we were selling five dozen every night we had them on the menu and people would walk around Lahaina broadcasting, 'enchilada's at "Natural's" tonight'. I never had to cook anything else.

A year later the restaurant closed, and somehow I gravitated to a little health food store in Wailuku. I never told anyone I was an accountant and basically relegated myself to being the truck driver. The guys who were running the health food store had friends in similar businesses and farms on many of the islands. I told them that if they could organize and form one company they could probably lock in the State. That's when they found out I was an accountant and "Down to Earth" was born. "Down to Earth" became the largest natural food store chain in the islands, and I was their Chief Financial Officer and co-manager of their biggest store for 13 years.

In 1981, I started to do a weekly radio show to try and expose people to a vegetarian diet and get them away from killing innocent creatures. I still do that show today. I pay for my own airtime and have no sponsors to not compromise my honesty. One bit of a hassle was the fact that I was forced to get a Masters Degree in Nutrition to shut up all the MD's that would call in asking for my credentials.

My doing this radio show enabled me, through endless research, to see the corruption that existed within the big food industries, the big pharmaceutical companies, the biotech industries and the government agencies. This information, unconscionable as it is, enabled me to realize how broken our health system is. This will be covered more in depth in the Introduction and throughout the book and when you finish the book you will see this clearly and it will hopefully inspire you to make changes.

I left Down to Earth in 1989, got nationally certified as a sports injury massage therapist and started traveling the world with a bunch of guys that were making a martial arts movie. After doing that for about four years I finally made it back to Honolulu and got a job as a massage therapist at the Honolulu Club, one of Hawaii's premier fitness clubs. It was there I met the love of my life who I have been with since 1998. She made me an offer I couldn't refuse. She said," If you want to be with me you've got to stop working on naked women". So, I went back into accounting and was the Chief Financial Officer of a large construction company for many years.

Going back to my Newark days when I was an infant, I had no idea what a "chicken" or "egg" or "fish" or "pig" or "cow" was. My dietary blueprint was thrust upon me by my parents as theirs was thrust upon them by their parents. It was by the grace of God that I was able to put things in their proper perspective and improve my health and elevate my consciousness.

The road that I started walking down in 1975 has finally led me to the point of writing my book, “A Sane Diet For An Insane World”. Hopefully, the information contained herein will be enlightening, motivating, and inspiring to encourage you to make different choices. Doing what we do out of conditioning is not always the best course to follow. I am hoping that by the grace of the many friends and personalities I have encountered along my path, you will have a better perspective of what road is the best road for you to travel on, not only for your health but your consciousness as well.

Last but not least: after being vaccinated as a kid I developed asthma, which plagued me all of my life. In 2007 I got exposed to the organic sulfur crystals, which got rid of my asthma in 3 days and has not come back in over 10 years. That, being the tip of the iceberg, has helped people reverse stage 4 cancers, autism, joint pain, blood pressure problems, migraine headaches, erectile dysfunction, gingivitis, and more. Also, because of the detoxification effects by the release of oxygen that permeates and heals all the cells in the body, it removes parasites, radiation, fluoride, free radicals, and all the other crap that is thrust upon us in the environment by Big Business.

For more, please view www.healthtalkhawaii.com and www.asanediet.com.

Namaste!