FedUpUSA

EpiPen: Only The Most Recent Price-Fixing Scandal

Growth Hormone Pen Delivery Device

Nearly 20 years ago, I was diagnosed with Adult Growth Hormone Deficiency (AGHD). I know many people will wonder what an adult needs with growth hormone, but what most people fail to understand is, that Growth Hormone (GH), produced in the pituitary gland, is the ‘mother hormone.’ This means all other hormones are controlled by GH. My own personal symptoms were a study in agony. Everything from severe migraines, to fatigue, to ‘female’ hormonal imbalances…which had led to PCOS and severe endometriosis…which then resulted in multiple surgeries. I was fortunate to get a diagnosis at all, and it was only because my son was being evaluated for childhood Growth Hormone Deficiency (GHD) due to his failure to grow, that my own deficiency (AGHD) was discovered.

As luck would have it, the endocrinologist to whom we were referred for my son’s evaluation was one of the country’s leading researchers into AGHD. This was due to the fact that our doctor was older, and had a long-running, large patient base which he had seen grow up and become full-height adults, only to find that they had a whole host of problems as adults after ceasing Growth Hormone Therapy (GHT). This led him to research into the role that GH plays in adults. What was clear from his research, and that of other like-minded doctors across the country, was that GH is essential for the creation of all other hormones in the body, and that this need does not change with the cessation of active linear growth.

At the time of my initial testing/evaluation, the diagnostic procedure included a drug called Geref made by a pharmaceutical company called Serono. It is a growth hormone releasing hormone (GHRH), meaning it’s not synthetic, but it’s basically a compound of proteins and amino-acids that kick your pituitary gland in the butt, prompting it to make growth hormone on its own. In some cases, people do not respond to Geref because their GH problem lies in the pituitary gland itself, and no amount of poking and prodding will cause the gland to produce GH. However, for many like me, the GH deficiency is not caused by a defect in the pituitary gland itself, it is caused by a messaging interruption, and for this issue Geref was the most effective treatment.

Serono Old

The testing showed that Geref successfully stimulated my pituitary to make GH, therefore, Geref could also be a highly effective therapeutic agent. So, not only did my testing fully reveal my problem, it also provided the drug to treat the problem. For about 6 years, I used Geref daily and the cost was relatively reasonable (about $200/month a portion of which was paid by my insurance carrier). The change this therapy made in my life was not trivial. For the first time in many years, I was able to lead a normal life without pain and without struggling to get through most normal activities.

All this changed however, due to FDA and FTC regulations which specifically allow monopolies and collusion by and among our pharmaceutical companies, despite being in direct violation of 15 U.S.C. Sherman Anti-Trust. Enter Merck. They, along with 2 other large pharmaceutical companies, developed rGH (Recombinant Growth Hormone DNA therapy – a/k/a synthetic growth hormone). This drug was 500% more expensive than Geref and does not act in the same way. Synthetic GH does not prompt the pituitary gland to produce GH, it just delivers a specific dosage of synthetic GH directly into the bloodstream. This therapy was obviously developed to treat those people who had a primary pituitary disorder (as opposed to the messaging problem like me), and who did not respond to GHRH/Geref.  This synthetic treatment can be most effective in children, because it provides the most linear growth at a time in which human bodies need the highest concentration of GH. It is however, much less desirable for adults when need for GH does decline as age progresses. Make no mistake though; humans need GH, even if just small amounts, to sustain life. A human being will die without GH.

Merck didn’t like that it couldn’t market to people like me, effectively making their market only 50% of all GH patients. They wanted everyone to have to buy their more expensive product. After all, why would anyone pay more for a drug they didn’t really need for their specific problem when a perfectly effective, lower cost alternative was available? At the same time, the other 2 drug companies had developed a pen delivery system for the rGH and they packaged them together along with Merck’s synthetic rGH. The new packaged synthetic GH medications (under a number of different brand names) with their fancy delivery system cost $5,800/month!

M_SER_R_4c

Merck’s solution to their market barrier was for them to buy Serono in order to control the distribution and use of the lower-priced Geref. So, they did just that in 2007. The first thing the new Merck-Serono did was make Geref no longer available for therapeutic use! This, in effect, destroyed their only competition. Merck-Serono, now as the owner of Geref, was permitted to do this because of the FDA regulations allowing such behavior, despite any patient need or demand.  Ultimately, what they did was buy the competition so they could discontinue it entirely and thereby eliminate the only obstacle to their market!  Therefore, my doctor had no choice but to switch my treatment to the new synthetic GH with its fancy delivery system and exorbitant price. Thus, this forced a market where there had previously been none.  Unfortunately, the synthetic GH didn’t work for me – basically, it gave me far too much GH, which is nearly as bad as not having enough; it is just a slightly different set of problems.

My doctor and I both appealed to Merck-Serono and the FTC, and we could not get them to provide any Geref. They cited the regulations protecting the drug companies’ autonomy over the prices and availability/distribution of products they own. Because of this, for years I went unmedicated, because the synthetic GH caused as many problems as I originally had prior to being diagnosed GHD.  It set my life and progress back to the point that it was as if I’d never been treated. My health deteriorated very quickly and ultimately resulted in my having to have radical surgery to remove my uterus, ovaries and repair massive damage to my kidneys, liver, bladder and colon due to the rampant progression of endometriosis. On top of that, the multiple weekly migraines, the agony of the pain, and the complete inability to sleep (GH controls sleep patterns), together made me frequently lose the will to keep living. What hurt most was knowing that the medication I needed existed, had been used for years, was proven save and effective, but was being denied to me by both its manufacturer and my own government.  My life-saving medication could not be obtained at any price, but for $5,800/month I could have its ineffective synthetic GH ‘replacement.’ I was told by the FTC, Merck-Serono, and my insurance company that I was the one refusing available treatment.

(As a side note, this expensive synthetic GH is the same product we hear about ad nauseum in the news with regards to its illegal use among sports figures. The GHRH, Geref, was not and is not effective for this type of use. So, even though there is evidence that this expensive synthetic is being abused, and Geref is not at all useful in this regard, it is still denied for therapeutic use for patients in need.)

Sadly, it doesn’t stop there. Because Geref was still available for diagnostic purposes (the stimulation tests for diagnosis), savvy doctors were trying to prescribe the diagnostic medication Geref for patients in need. My doctor tried this himself, but the quantities available were insufficient for long-term therapeutic patient use. This obviously led Merck to be concerned that if doctors were administering Geref for diagnostic tests, it demonstrated to the doctors that Geref was an effective therapy merely by its action during the testing procedure. So, the next thing Merck-Serono did was to ban Geref for diagnostic testing.  They were legally able to yet again destroy this barrier to their target market by eliminating availability to a product they owned thanks to FDA and FTC regulations that permit such behavior despite any patient need.

The additional tragedy of this is that the alternative testing method is not only substantially less effective, it can be downright dangerous. The current testing method involves an arginine stimulant agent instead of the releasing hormone to stimulate the pituitary. Arginine is contraindicated for anyone with diabetes or insulin resistance. The vast majority of patients with GHD (either adult or child) have some level of insulin resistance. This means administration of arginine has an extremely high risk of causing diabetic shock. I experienced this myself during my doctor’s administration of this new diagnostic test. I can say it is an experience I would never want to go through again. Many endocrinologists (rightly) do not want to even administer the GHD stimulation test using the now-only-method-available arginine-based procedure, due to the high risk of death. Most will no longer perform the test, leaving many patients undiagnosed, and the rest will order a hospitalization for administration of the test. So, Merck-Serono has made what was a relatively simple, in-office, precise diagnostic test into something that is so potentially life-threatening that it requires hospitalization. The result is that endocrinologists avoid dealing with growth hormone deficiency altogether. With the passage of time, fewer and fewer endocrinologists are even aware that there used to be an alternative diagnostic testing method that was safer and more effective. Ultimately, new endocrinologists are not even being taught about the existence of Adult Growth Hormone Deficiency at all, and many will not attempt to diagnose or treat children who fail to grow.

Thankfully, I did not give up. I kept looking for some way to get effective treatment. By acquiring a ‘wellness doctor’, what I found was that compounding pharmacies, can easily make what I needed. With Geref, being comprised of simple proteins and amino-acids, and the combination thereof not being patented, compounding pharmacies were making its generic equivalent available. So, 5 years ago I was able to begin purchasing my generic Geref (semorelin) from a compounding pharmacy via mail order. It costs me approximately $360 every 4 months (this is a cash price, since insurance will not cover this.)

I’m sharing this after so many years because of the recent headlines regarding Mylan and the EpiPen. They made the national news because far more people need epinephrine than need GH. However, what they did is the same old story; it’s identical to what Serono and Merck and the other two developers of delivery devices did years ago in my case. I want people to know that our healthcare system is corrupt. It has nothing to do with capitalism. It has to do with legalized CRIME. Pharmaceutical companies have lobbied Congress for regulatory bodies such as the FDA and FTC to protect their ability to create monopolies and collude to set prices.

When one company develops something that is more expensive than an existing product, mergers, acquisitions, and collusion to fix prices and deny availability ensue. This is how we have $700 EpiPens and $450 insulin. It is not because they are expensive to make. These same items are $57 and $15 respectively in Paris, for instance and the manufacturing costs are less than half that price. The regulatory (FDA) prohibition on bringing drugs back into the USA from out of the country has nothing to do with protecting people’s health (they’re the SAME drugs by the same manufacturer), it is to protect the price fixing! In any other sector of our economy, in any other industry, this would be illegal under 15 U.S.C. collectively known as the Sherman Anti-Trust Act as well as 18 U.S.C. Any other industry would have already been brought up on RICO charges. However, because the regulatory bodies fully encourage and protect this behavior by pharmaceutical companies, medical device manufacturers, and insurance companies, and the Congress is being unjustly enriched by the lobbyists, along with their inside, private investments in these same companies, nothing is done by the government to stop this. In fact, the government has CREATED this situation BECAUSE it enriches them. Our healthcare system works solely on the basis of stealing from the public, and enriching those in power who facilitate the theft. In other words, it is an enormous PAY TO PLAY SCHEME. The medical industry pays for its ability to collude and fix prices, and Congress gets richer. Meanwhile, Americans suffer and die in what is supposed to be the freest nation on Earth. More like the most corrupt.

Until or unless something is done to stop this, government/corporate cronyism effecting access to our healthcare, Americans will continue to suffer. Sadly, most Americans don’t understand this is happening, and believe the platitudes and promises of ‘healthcare reform’ and ‘affordable care’ spewed by the very same government that is robbing them in the first place.  (Note that it has been revealed that massive amounts of taxpayer dollars began being sent to Mylan after Senator Manchin’s daughter became CEO.  This means the very people who cannot afford an EpiPen have been sending their taxpayer money to enrich the company that makes the lifesaving device they can’t have!)  This is NOT a partisan issue and it is not isolated to a few companies.  These broad regulatory protections to the health care industry began in the 1980s, continued through the 90s and have culminated in the Affordable Care Act, which essentially further preserves the regulations while promising lower prices.  Two things that are polar opposites and thereby impossible.  

Those of us old enough to remember the 70s and early 80s can remember paying (or our parents paying) for doctor visits and medications with cash.  A patient would walk into the doctor’s office and the price of the services were clearly posted.  Ditto with going to the pharmacy to buy a medication.  Sometimes your doctor would actually fill your prescription right there after telling you the price would be $10.00.  That’s because it was prior to the regulatory protections for medical monopolies and price fixing.  The general public was just told it was ‘rising costs of healthcare.’  Because a consumer has to purchase a medical service, device or medication without knowing the real price up front (more FDA/FTC/insurance regulations), the general public believed it was just ‘rising costs’ because the hidden protections aren’t blatantly evident, and it just looked like prices were rising dramatically due to ‘advancement’ in care and production.  Did this happen to the price of your TV,computer, or mobile phone?  

Medicine has not advanced so much that it has surpassed the pace at which technology has progressed.  Indeed there is evidence that advancement in medicine has lagged far behind what it could otherwise be if not for the price and monopoly protections. This is what happens when competition has been eliminated and the game is all about who can afford to purchase the most favorable regulations from Congress. Still no cure for cancer.  Still no cure for diabetes.  The reason for this is because sickness generates profit and the prices of these services and medications that ‘treat’ these diseases can be fixed to never come down and actually fixed to go up through industry collusion! This price-fixing, elimination of competition and collusion also leads to a proliferation of ‘snake oil’ (bogus and dangerous medications), but that’s a whole separate article. Meanwhile mobile phones have gone from the size and weight of a brick to the size of a credit card and back up to the size of a Pop-Tart but without the weight of a brick; computers have gone from filling entire rooms to the size of a small car, to the size of a tablet….and the prices have all come down exponentially!  This is because the companies that manufacture these items are not afforded regulatory price-fixing protection.  They have to compete to have the best product in order to gain customers, not so for the healthcare industry.  We are a captive audience for the healthcare companies!

Mobile Phone Evolution

Mobile Phone Evolution

There have been notorious anti-trust suits in the technology industry and all have resulted in more competition, not less.  Ask Bill Gates. This is exactly the opposite of what we see in all sectors of the medical industry.  In what other industry could one company collude to buy out another company with the sole purpose of eliminating the product the purchased company makes in order to corner the market on that particular product?!  The last big industries that did that owned railroads and oil companies.  The healthcare industry needs to have happen exactly what happened to Mellon, Carnegie and Rockefeller.  The healthcare industry is nothing less than the modern Robber Baron on an enormous scale, and with much more government participation.  However, I will remind the reader that 15 U.S.C. trumps ANY regulatory body.

As I illustrated above, there are some things you can do to help yourself. The first thing is to stop relying on your doctor. This is a tall order, but it’s your health and your life. I’m just an ordinary person, but I think you can see from this article, that I know more than a little bit about the endocrine system. This is a highly specialized field of medicine, but I was able to teach myself much of what I needed to know. Resources are everywhere. I can confidently run circles around most recently-educated endocrinologists. Unfortunately, I’m not compensated the way they are – but my knowledge is invaluable to me, because I saved my own life. You can too. You may not get to earn the salary of a licensed MD, but you can reap the best benefit of all, your quality of life. If you are one of the few that have been at the mercy of Mylan, you can start with this…

EpiPen Alternative

 

FedUpUSA

Share

Comments

comments