As usual, big Pharma only wants as much of your money they can get. In a recent article in USA Today on 5/28/18, Sydney Lupkin of Kaiser Health News makes that very clear. Here Goes:
“Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition by potentially stalling generic competition have raised their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis found.
As part of President’s Trump’s promise to curb high drug prices, The FDA posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.
The analysis shows that drug companies that may have engaged in what FDS Commissioner Scott Gottlieb called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.
The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster drug Revlimid, which accounted for 63 percent of Celgene’s revenue in the first quarter of 2018, according to a company press release.
The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t such lucrative sources of revenue” said Harvard Medical School instructor Ameet Sarpapateari. “In case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”
A KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drug-makers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data is available. The remaining drugs do not appear in the Medicare and Medicaid data.
By delaying development of generics, drug-makers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 6-% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.
Revlimid cost Medicare Part D $2.6 billion in 2016, trailing only Harvoni, which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just four years, the Medicare data show and costs $75,000 per beneficiary in 2016.
Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require distribution of brand-name drugs that have serious risks of addictive qualities. Drug-makers with products in the safety program sometimes say they cannot samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Gottlieb said in a statement.
The Department of Health and Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Satpatwari said there’s evidence drug-makers are abusing it to stave off competition from generics.
Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anti-competitive practices.
Celgene spokesman Greg Geissman said the company has sold samples to generic manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition and safety. “Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks,” Geissman said.
The highest pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer. In 2016, that drug cost Medicare $90,700 per patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.
Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen in 2017.
Actelion spokeswoman Colleen Wilson said that the company “cooperates with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”
PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses form those it represents.
PhRMA spokesman Andrew Powaleny said, “While we must continue to foster a competitive marketplace. PhRMA is concerned the FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios.”
Congress is considering CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.
The bill’s sponsor, Sen. Patrick Leahy, D-Vt., said more transparency from the FDA is helpful, but more work from the agency is needed to end the anti-competitive tactic. “With billions of dollars at stake, a database alone will not stop this behavior,” Leahy said.
Co-sponsor Sen. Chuck Grassley, R-Iowa, chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anti-competitive practices to keep low-cost generic drugs off the market.”
The FDA hasn’t come out in support of CREATES. “they should know that this is going to require a legislative solution,” Sarpatwari said. “Why are they not saying that?” “
My comments:
The FDA is run by former pharmaceutical and biotech employees. You stay sick and they stay rich. To break that trend, take a look at “A Sane Diet for an Insane World”.
Aloha!
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!
