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CGRP -A New Class of Drugs
What to know about the new Anti CGRP
migrain treatment options
| Drug Pricing Reform
Drug prices are at a ridculous high. It’s time
to change.
PHARMECOGENTIC TESTING
The new frontier of medicine begins here

CONTENTS
September 2018
FEATURES
CGRP - A New Class Of Drugs 2
What to Know About the New Anti CGRP
Migraine Treatment Options
Pharmecogenetic Testing 10
The New Frontier of Medicine Begins Here. . . .
Drug Pricing Reform 18
It's time to change
DEPARTMENTS
MEDICAL 8
Back to School Tips
Preperation for school goes farther than backpacks
INTERNATIONAL 16
Drug Use - America Vs. Europe
America, when compared to European nations, is in the top five
countries for almost every national measure of drug abuse.
CHRONICLES 24
Diabeties - A New Cure
The Daniel Plan-a social experiment to learn if
community support was more effective than medication

CGRP
A New Class of Drugs
What to Know About the New Anti CGRP
Migraine Treatment Options
In groundbreaking news for the migraine community, the FDA recently approved
the first anti CGRP migraine treatments specifically created to prevent
migraine. Designed to target CGRP, the protein known for causing migraine,
these treatments are the biggest news in migraine treatment and
prevention in decades. With one treatment option released on the market and
three more expected in the next year and a half, migraine patients are asking
if these treatments apply to them. The American Migraine Foundation sat
down with Dr. Stewart Tepper, a professor of Neurology at the Geisel School
of Medicine at Dartmouth and Director of the Dartmouth Headache Center
at the Dartmouth-Hitchcock Medical Center, to answer the most pressing
questions surrounding the monoclonal antibodies designed to target CGRP
and the CGRP receptor.

What is CGRP?
CGRP stands for calcitonin gene-related peptide, and it is a
protein that is released around the brain. When CGRP is released,
it causes intense inflammation in the coverings of the
brain (the meninges), and for most migraine patients, causes
the pain of a migraine attack. In fact, if you give CGRP by an
intravenous method to a person with migraine, within four
hours, most of them will get a migraine. That’s the basis of all
the new treatments.
How do the new drugs work and what is
their relationship to CGRP?
Once it was determined that CGRP caused migraine, it became
clear that if we could do something to stop CGRP, we
could probably stop migraine. Four companies decided to
create antibodies against CGRP and against the receptor to
which CGRP binds. These large molecules are called monoclonal
antibodies, and they do not cross into the brain. They
are not eliminated by the liver. In fact, they are such big molecules
that they have to be injected to get into the system. The
drug approved last week, which is called erenumab, the brand
name of which is Aimovig, is a monoclonal antibody against
the CGRP receptor. The additional three are monoclonal antibodies
against the CGRP protein.
What kind of side effects come
with these treatments?
These drugs are extremely well tolerated. In fact, for most
people, they don’t seem to have significant side effects
other than some pain at the injection site.
How fast can one expect to see results?
With these new drugs, the monoclonal antibodies, most patients
who are going to respond will see significant clinical
benefit within a month. They are fast. For typical preventive
medications, we usually work up to the correct dose and then
we wait three months to see whether they’re effective.
How are these drugs administered?
The first three of the treatments are going to be by patient
self-injection with a subcutaneous auto-injector at home.
Some migraine studies estimate that 13 percent of
adults in the U.S. population have migraines, and 2-3
million migraine suffers are chronic. Almost 5 million
in the U.S. experience at least one migraine attack per
month, while more than 11 million people blame migraines
for causing moderate to severe disability.
Two of them will always be monthly, and one of them will be
either monthly or quarterly self-injection. The fourth one is
going to be available by an intravenous infusion, which will
be given every quarter, but patients would have to come into
the doctor’s office to receive the fourth one, which we would
expect at the end of next year or in 2020.
Who will benefit from these treatments?
The monoclonal antibodies have all been studied in episodic
migraine and in chronic migraine and work in both, and
they’re approved by the FDA for both, which is significant.
These treatments are effective for migraine with aura or migraine
without aura, for medication overuse and for no medication
overuse. They have been proven to work in patients
who have had a lack of success in two, three, and four previous
preventive medications.
How much relief can patients
expect to receive?
For patients with episodic migraine, that is less than 15 headache
days per month, the new drugs dropped the number of
migraine days per month by two to four days, generally around
four days. If you multiply four days per month of no migraine
times 12 months, then you have 48 days of no migraine per
year, that otherwise would have been migraine days. That’s
roughly a month and a half of no migraine per year compared
to no treatment.
For the chronic migraine patients, those who have headache
15 or more headache days per month, these drugs dropped
the number of migraine days by six to eight days per month.
Of course, people with chronic migraine have more headache
days per month to begin with, but six to eight days per
month multiplied by 12 means that people could be expected
to have at least two and a half months of no migraine,
even three months of no migraine per year that they previously
had migraine. That’s a pretty dramatic drop in the
number of days of no migraine in a year and per month.
That’s why we’re very, very excited.
Are there any reasons, another question,
for pre-existing health condition or
another medicine that would prevent
somebody from receiving the treatments?
Erenumab, the drug that was approved, has been studied in
patients with angina and heart disease. In that study, there
was no impact on the angina in patients with pretty frequent
angina. Erenumab has also been studied in people
with risk factors for coronary disease and vascular disease
without problems noted. There don’t seem to be any drug
interactions that we know of with these monoclonal antibodies
and other treatments. People would still be able to
use their acute treatments when a migraine breaks through
because for most people, these are not going to completely
eliminate migraines. They’re going to help with frequency,
severity, and duration.
Should people living with migraine approach
this treatment option with caution,
or is it a viable option for most?
I think that the insurance companies are going to limit the access
to these drugs to people who have had a lack of success
with two or three of the conventional preventive medications.
Having said that, the one that was approved, erenumab was
studied in people who had already had two to four preventive
medication failures, and I mean complete failures. These were
people that had taken antidepressants, anti-epilepsy drugs,
anti-blood pressure drugs that were supposed to be effective
for migraine prevention, and they had not worked at all. Then,
they were given the monoclonal antibody, and it still seemed
to work. The other monoclonal antibodies are also being studied
people who have had a lack of success with their previous
preventive treatments, and they also very good in terms of
likelihood of success, even though people have had a lack of
success with previous treatments. This text is for the sake of
visual alighnment beause without it the columns do not line
up. I do hope that I am not making a terrible mess.
Amgen and Novartis have claimed the first approval for
a CGRP inhibitor in migraine, getting an FDA green light
for their Aimovig product ahead of rival drugs from Eli
Lilly, Teva and Alder Biopharma.
Still, I don’t think we would give everybody with migraine this
treatment option, because we’re likely to be limited by insurance
and by cost. The more disabled people, the people that
have tried the hardest and done the most and have still had a
lack of success in reducing their migraines, are the candidates
for whom these medicines should be made accessible.
Are the treatments expected to work for
most migraine cases or for only specific
types of migraine or symptoms?
These monoclonal antibodies were tested for migraine with
aura, migraine without aura, episodic migraine, chronic
migraine, medication overuse headache, and they worked
equally well in every single one of those groups. If you are
somebody who’s very disabled by migraine and has had a lack
of success with prevention and if you currently have commercial
insurance, a monoclonal antibody would be a very reasonable
option.
If these treatments have been said only to
alleviate a few headaches a month. Would
it be worth it for me to try?
It is a gross under-estimate to think that these are only going to
alleviate a few days per month. I think they’re going to reduce
not just the frequency of migraine days per month but the
intensity and the duration of the attacks, and they will likely
help with the acute treatments as well because when people
get their foot off the accelerator, the brake works better. They
have also been shown to reduce the number of acute migraine
treatments people need to take per month.
Are these treatments safe for women who
are pregnant?
I certainly don’t want my patients who go on these to get pregnant.
I am going to ask my patients to have very good birth
control in place before we initiate the treatment. We don’t
know about pregnancy safety, but monoclonal antibody effects
last for months, and I don’t want one of my patients to be
the one to try to find out whether there is a problem.
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Is the treatment available only in
the United States?
The United States is the first country to get the first anti-CGR-
Preceptor monoclonal antibody, and we are the only country
that has erenumab available.
Why is this so groundbreaking
for migraine patients?
We’ve never had preventive medication designed for migraine
in our lifetime. We’ve never had preventive medicines that are
very, very well tolerated. All of our current preventive medicines
have side effects that often prevent people from using
them. We’ve never had preventive medicines that kick in and
give significant clinical benefit within a month. If you add all
of that up, this really seems like a watershed moment.
I really feel like the ground is shaking under our feet. I feel like
this is a time when prevention and the way we treat migraine
is about to change for the better, and I’m extremely happy for
people with migraine across the country at this time.
What’s next?
If you think you may be a candidate for this new type of migraine
medication, talk with your doctor, and perhaps ask for a
consult with a neurologist or headache specialist who can help
you understand more about the medication. Monoclonal antibody
therapy is expensive, and there will likely be regulations
about for whom s the treatments are appropriate. Much more
research needs to be done about who is the best candidate for
this therapy. But for many migraine patients who have not responded
to the standard treatments, or who have had intolerable
side effects such as cognitive dysfunction, low blood pressure,
weight loss or gain, or other issues, CGRP monoclonal
antibodies are safe and well tolerated, and are an exciting new
development for migraine therapies.
Monoclonal antibodies target either CGRP or the CGRP receptor
and are used for migraine prevention. A monoclonal
antibody is a collection of identical proteins that have been
developed to only target one substance in the body. They are
given by injection subcutaneously (under the skin), to avoid
degradation by the stomach. Because they are large molecules,
they take longer to start working and work in the lining of the
brain rather than in the brain itself. They also tend to have
few drug interactions and are unlikely to cause liver or kidney
damage. Currently, three CGRP inhibitors that are monoclonal
antibodies have been approved:
⚛ Aimovig (erenumab-aooe): Approved May 17, 2018
⚛ Ajovy (fremanezumab): Approved Sept 14, 2018
⚛ Emgality (galcanezumab-gnlm): Approved Sept 27, 2018
⚛ Eptinezumab: Not yet approved.
Gepants are small molecule drugs which block the CGRP receptor
and are still being investigated for both migraine relief
and prevention. Unlike monoclonal antibodies, gepants
rapidly penetrate the brain so work quickly; however, they are
metabolized in the liver so there is a higher potential for interactions
and possibly liver damage. Examples include ubrogepant,
atogepant, and rimegepant.
CGRP inhibitors are the first drugs to be developed specifically
for migraine prevention. All other migraine preventive agents
were originally developed for other conditions (such as high
blood pressure), and then found later by chance to have an
effect in migraine.
Once it was determined that CGRP caused migraine, it became
clear that if we could do something to stop CGRP, we
could probably stop migraine. Four companies decided to
create antibodies against CGRP and against the receptor to
which CGRP binds. These large molecules are called monoclonal
antibodies, and they do not cross into the brain. They
are not eliminated by the liver. In fact, they are such big molecules
that they have to be injected to get into the system. The
drug approved last week, which is called erenumab, the brand
name of which is Aimovig, is a monoclonal antibody against
the CGRP receptor.
For more information on the new anti CGRP treatments,
please contact your healthcare professional. ⚛
IN REVIEW
⚛ Multiple studies have confirmed that release of
calcitonin gene-related peptide (CGRP) is increased
during acute migraine attacks.
⚛ In the trigeminal ganglion, CGRP is expressed in
C-fibres and its receptor is expressed in Aδ-fibres;
these types of fibres are involved in different aspects
of pain perception.
⚛ The trigeminal ganglion is central to the trigeminovascular
reflex, which is triggered to protect against
vasoconstriction; triggering of this system in patients
with migraine leads to the perception of pain.
⚛ The trigeminal ganglion and dura are not behind
the blood–brain barrier; therefore, they are likely
to be the targets of gepants and antibodies in
migraine treatment.
⚛ CGRP receptor antagonists, anti-CGRP antibodies
and anti-CGRP receptor antibodies have proved
effective for migraine pain relief, strongly supporting
the hypothesis that CGRP has a major role in
migraine pathophysiology.
"CGRP is the most potent
vasodilator of human cerebral
arteries."
Frederick R. Taylor, MD, Adjunct
Professor of Neurology at Minnesota
University in Minneapolis.
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9

Medical
Back To School Tips
Many of us have been busy these past few weeks getting
our kids ready for the school year. If your child is one
of the 6.5 million kids in the U.S. being treated for a
chronic medical condition such as asthma or diabetes,
your preparation involves more than new backpacks
and glue sticks.
Keep tabs on the supply:
If the medication will be stored at school,
check often to ensure there is an adequate
supply so there are no missed doses. Make
sure the medication stays in its original
container and label.
School
·Staff
Know how your child will receive
the medication:
Will he or she be expected to report
to a certain place at a certain time,
or will she be called to do so? What
is the policy for field trips?
If your child uses an epi pen.
it’s important to make sure they have one
for home and one for school. Ask your doctor
to indicate on the actual prescription
that the two injectors are for home and for
school, so that in case of a life-threatening
anaphylactic reaction, the school can be
prepared.
Know your school’s rules:
Who is allowed to administer
medication, and who fills in if the
person is absent? Is your child
allowed to carry the medicine
and take it without supervision?
Provide clear instructions:
Prepare a typed list of all medications with
warnings and storage requirements. Also
include an action plan school staff can
refer to in an emergency. Make sure your
child, teachers and the appropriate school
administrator have current copies.
Juvenile diabetes
Your school nurse should be familiar
with both type 1 and type 2
diabetes. Your child’s school should
have a refrigerator to store insulin
vials or pens, if needed, as well as
staff trained in diabetes care.
Get vaccinated.
Flu vaccines are recommended for everyone
six months and older, and vaccinations
can reduce illness and keep the
flu from catching—especially in environments
like schools where germs can
spread quickly.
Keep your child informed:
A.M. game plan:
Your child should be aware of the
School mornings can be hectic, so
basics of his condition – signs of
try to integrate the morning dose
an allergic reaction, a flare-up or
into the morning routine. Also
side effects of the medication. Your
have a back-up plan in place if that
child should know proper dosages
morning dose is missed and your
10
and be aware of when and how
child needs to take it at school.
often he is supposed to take it.
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The New Frontier of Medicine Begins Here. . . .
We are on the cusp of a fascinating new era of healthcare, literally a new
frontier in the world of medicine. Genetic variability has long been accepted
and promoted within both the scientific community and the healthcare
industry. Advances in molecular testing, and completion of the mapping
of the human genome in particular, give credence to the fact that patients
respond differently to medications based on their individual genetic makeup.
Such advancements brought about the concept of personalized medicine,
the practice of using an individual’s genetic profile to guide decisions
for the prevention, treatment and diagnosis of disease. Correspondingly,
a major problem in the healthcare industry is the variability of drug efficacy
from patient to patient. While some patients complain about lack of
effectiveness, other patients suffer from adverse drug reactions (ADRs).
Personalized medicine has the ability to alleviate the burden of individual
genetic variability and the resulting varied drug response across
different patient populations.
Pharmeco
Genomic
Testing

In the United States, ADRs create up to $100 billion in costs
annually, and over 120,000 deaths every year. Accordingly,
ADRs have been described as the fourth leading cause of
death in the United States, only surpassed by heart disease,
cancer and strokes. Studies attribute 6.5% of hospital admissions
to ADRs, with the average hospital stay estimated at
four days. On average, ADRs extend patient hospital visits up
to four days, which result in additional fees of up to $46,000;
so for a 350 bed hospital, managed care costs associated with
ADRs are approximately $2.8 million annually. Addressing
the health and cost implications of ADRs, personalized medicine
facilitates cost containment while improving patient
Genelex has been a leader in pharmacogenetic testing
since 2000. Our high-complexity laboratory facilities
feature robotic DNA extraction and testing, proprietary
test platforms and methodologies, rapid-turnaround,
and test validation across multiple platforms.
care and quality of life. Aside from the resulting financial
burden, ADRs significantly impact health outcomes; patients
Pharmacogenomics testing
reviews individual genetic
makeup to identify the likelihood
of ADRs, thereby reducing
occurrences among the patient
population;
report decreased quality of life, which often results in more
testing to identify the cause of their symptoms. An often overlooked
consequence of ADRs is the impact on patient adherence.
Patients neglect to follow prescription guidelines due to
their lack of faith in drug efficacy or the belief that they are
prone to side effects from their medications.
A solution to ADRs and lack of medication efficacy is pharmacogenomics.
Pharmacogenomics testing reviews individual
genetic makeup to identify the likelihood of ADRs, thereby reducing
occurrences among the patient population; increasing
drug efficacy; increasing adherence through patients’ first hand
positive experiences, encouraging treatment continuity; and
reducing healthcare costs incurred from ADRs, poor efficacy
and lack of patient adherence. Pharmacogenetics is the study
of how a person’s genetic makeup affects the metabolism of
medications.
Pharmacogenetic testing (PGx) detects normal and single
nucleotide polymorphism (SNPs) in the alleles of genes
and their associated enzymes. PGx results therefore predict
a person’s ability to metabolize certain medications. From a
patient effectiveness standpoint, it’s the next major breakthrough
in medicine. Pharmacogenetic testing (PGx) results
provide physicians with concise, medically actionable information
about a patient’s genotype, thus allowing them to
make effective treatment decisions. Because a patient’s genotype
remains constant, PGx results can be used to inform
medical treatment throughout their lifetime. Utilization of
PGx tests by physicians and healthcare providers will drive
the reduction of patient ADRs, while concurrently increasing
drug efficacy and patient adherence. As such, adoption of proactive
pharmacogenomics testing will lower healthcare costs
and improve patient quality of life.
Pharmacogenetics testing can be particularly
useful in:
· Chronic pain management
· Knowing a patient’s genotypes prior to prescribing pain and
other medicine
· Minimizing debilitating side effects
· PGx testing can mean the difference between a treatment
failure and a successful outcome.
You will know the following critical information for your patient:
· Which medication will work BEST
· Which medication will NOT work
For some insight to what awaits us, here is a 4-minute video,
The Era of Personalized Medicine, featuring the ‘Father of Pharmacogenomics’,
Dr. Richard Weinshilboum, the Director of
Pharmacogenomics at Mayo Clinic, and a 2-minute Mayo Clinic
video, The Importance of Pharmacogenetics: 2 min - Mayo
Clinic - Importance of Pharmacogenetics 4.5 min - The Era of
Personalized Medicine
Drug-gene testing is also called pharmacogenomics, or
pharmacogenetics.
All terms characterize the study of how your genes affect your
body’s response to medications. The word “pharmacogenomics”
is combined from the words pharmacology (the study of
the uses and effects of medications) and genomics (the study
of genes and their functions).
Your body has thousands of genes that you inherited from
your parents. Genes determine which characteristics you have,
such as eye color and blood type. Some genes are responsible
for how your body processes medications. Pharmacogenomic
tests look for changes or variants in these genes that
may determine whether a medication could be an effective
treatment for you or whether you could have side effects to
a specific medication.
Patient Information: Pharmacogenomics –
Finding the Right Medication for You
Pharmacogenomic testing is one tool that can help your
health care provider determine the best medication for you.
Your health care provider also considers other factors such as
your age, lifestyle, other medications you are taking and your
overall health when choosing the right treatment for you.
WHAT PHARMACOGENOMICS
TESTING DOES
The purpose of p harmacogenomic testing is to find out if a
medication is right for you. A small blood or saliva sample can
help determine:
Whether a medication may be an effective treatment for you
What the best dose of a medication is for you
Whether you could have serious side effects from
a medication
The laboratory looks for changes or variants in one or more
genes that can affect your response to certain medications.
Each person would need to have the same specific pharmacogenomic
test only once because your genetic makeup does
not change over time. However, you may need other pharmacogenomics
tests if you take another medication. Each medication
is associated with a different pharmacogenomics test.
Keep track of all your test results and share them with your
health care providers.
The need for pharmacogenomics testing is determined
on an individual basis. If your pharmacogenomic test results
suggest you may not have a good response to a medication,
your family members may have a similar response.
Mayo Clinic recommends you share this information with
your family members. Your health care provider can also provide
recommendations for family members who may benefit
from having testing.
CURRENT LIMITATIONS OF
PHARMACOGENOMICS TESTS
Current limitations of pharmacogenomics testing include:
One single pharmacogenomic test cannot be used to determine
how you will respond to all medications. You may need
more than one pharmacogenomic test if you are taking more
than one medication.
Pharmacogenomic tests are not available for all medications.
Because pharmacogenomic tests are available only for
certain medications, your health care provider determines if
you need to have a pharmacogenomic test prior to beginning
a specific treatment.
There are currently no pharmacogenomic tests for aspirin and
many over-the-counter pain relievers.
PHARMACOGENOMICS TESTING
COSTS AND COVERAGE
The cost of pharmacogenomics testing varies depending on
which test is ordered and your health insurance coverage. To
help you determine test costs and coverage:
Mayo Clinic’s Patient Account Services may be able to provide
Most drugs are broken down (metabolized) in the body
by various enzymes. In some cases, an active drug is
made inactive (or less active) through metabolism. In
other cases, an inactive (or less active) drug is made
more active through metabolism. The challenge in drug
therapy is to make sure that the active form of a drug
stays around long enough to do its job.
an estimate by phone.
Some insurance companies may cover pharmacogenomic testing,
depending on the policy and reasons for testing.
Contact your insurance provider about coverage prior to testing
if cost and coverage are concerns.
It may be helpful to get the ICD-9/ICD-10 procedure and CPT
billing codes for the specific lab tests from your health care
provider before calling the insurance company.
A federal law called the Genetic Information Nondiscrimination
Act (GINA) generally makes it illegal for health insurance
companies to discriminate against you based on your genetic
information. This federal law does not protect you against genetic
discrimination by life insurance, disability insurance
14 15

The word “pharmacogenomics” is
combined from the words pharmacology
and genomics: Pharmacology deals with
the uses and effects of medications.
Genomics deals with understanding
genes and their roles.
or long-term care insurance companies. Some states have
laws in this area.
WHAT IS PHARMACOGENOMICS?
Pharmacogenomics, or pharmacogenetics, is the study of how
your genes affect your body’s response to medications. The
word “pharmacogenomics” is combined from the words pharmacology
and genomics: Pharmacology deals with the uses
and effects of medications. Genomics deals with understanding
genes and their roles. Genes carry information that you
inherit from your parents. Genes determine which characteristics
you have, such as your eye color and blood type. Your
genes influence how your body responds to medications.
WHY SHOULD I HAVE TESTING?
The purpose of pharmacogenomic testing is to find out if a
medication is right for you.
Pharmacogenomic testing can help to determine: how likely a
medication is to work for you, the best dose of a medication,
or if you could have serious side effects from a medication. A
pharmacogenomic test may help to predict your response to
one or a few medications. However, it cannot tell you how you
will respond to all medications.
GETTING THE RESULTS BACK?
Results for most pharmacogenomic tests are available within
a week or two.
WHAT SHOULD I DO WITH MY TEST RESULTS?
Talk to your health care provider or pharmacist about the results.
They may recommend that you: • keep taking a medication,
• change the dose of a medication, • stop taking a medication,
or • take a different medication.
HOW MUCH DOES TESTING COST?
The cost varies depending on which specific test is ordered,
but is usually a few to several hundred dollars. Mayo Clinic’s
Patient Account Services may be able to provide an estimate
by telephone.
IS TESTING COVERED BY MY INSURANCE?
Some insurance companies may cover pharmacogenomic testing,
depending on your specific policy and your reasons for
testing. Contact your insurance provider about coverage prior
to testing if this is a concern. It may be helpful to get the ICD-
9 procedure and CPT billing codes for the specific lab tests
from your health care provider before you call the insurance
company.
This is an up an coming field of research that is revolutionizing
the genetic testing as we know it. For more information,
visit our website and click on the helpful links.⚛
16 17

International
Drug Use
America Vs. Europe
The following chart and maps show an unfortunate reality: America, when compared
to European nations, is in the top five countries for almost every national
measure of drug abuse. And while some European countries show up in the top five
more often than others, none do as consistently as the U.S. This offers an opportunity
to understand what works and what doesn’t for different societies and potentially
find ways to fix our own.
A LOOK AT DRUG-RELATED ARRESTS
The U.S. has a reputation of harsh law enforcement practices
and criminal penalties when it comes to drug use,
possession, or sale. Unsurprisingly, it ranks high on the list
of total drug-related arrests – placing at No. 2 overall. However,
it pales in comparison to Spain – ironically, a country
in which drug possession is no longer a criminal offense.
This shows the massive challenge Spain faces as a port of
call for smugglers of all types of drugs from all around the
world – even Canadians have been arrested while trying to
bring illicit substances into Spain.
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COMPARING COCAINE USE
When it comes to previous-year cocaine use, the U.S. is tied
for first place with Spain, a nation having a drug crisis of its
own. Spain and Portugal offer an interesting contrast: Both
decriminalized possession of all drugs, “soft” and “hard,” in
the last decade, concentrating on civil fines and treatment
for users while reserving jail time for dealers.
While Portugal has been a success story and a model for
other countries, including Spain and Italy, Spain’s success
has been decidedly mixed. A number of differences between
the two countries – such as Spain’s decentralized government,
which allows regions to set their own drug policies,
and its long coastline facing drug smuggling routes from
North Africa – show there is no one-size-fits-all solution to
drug abuse.
PEOPLE IN TREATMENT FOR SUBSTANCE ABUSE
As seen on the maps above, the U.S. may have a much larger
problem with many drugs than most European countries
– but encouragingly, a significant portion of people are getting
help for their addictions as well. Compared to countries
which have also shown significant problems with drug use
among the public, such as Spain and Estonia, Americans
appear to be more active in seeking out and/or receiving
treatment: 75% higher than the runner-up, Malta. Unfortunately,
the number of people who are treated for drug abuse
and addiction is still dwarfed by the staggering number of
people who are using drugs to begin with.
YEARLY DRUG OVERDOSE DEATHS BY NATION
When it comes to yearly deaths by drug overdose, the U.S.
is in the company of Estonia, a Baltic nation where the
dangerously powerful opioid fentanyl is smuggled in from
Russia. However, it should be pointed out that these statistics
rely on death certificates issued by doctors, and studies
have shown that there can be substantial variations in what
doctors report on death certificates, both on a cultural and
individual level.
AVAILABILITY OF TREATMENT FACILITIES
The U.S. is near the middle of the pack when it comes to the
number of substance abuse treatment centers per capita.
However, keep in mind that this statistic does not take into
account the number of patients per center, which can vary
from country to country and is not available for many countries.
Ireland, infamous for its stereotype of alcoholism,
does have many alcohol drinkers as seen on earlier maps,
but likewise has many rehab centers to help them – about
39% more than the runner-up. Slovakia also ranks high
on this list due to the nation’s numerous publicly funded
opioid substitution therapy centers.
19

It's time to change
Under the current Medicaid reimbursement rules, pharmaceutical companies
have an incentive to inflate private-sector prices so they can collect higher rebate
prices from a large Medicaid customer base. The CMS could revise its rules to
specify how manufacturers calculate best prices determined after the sale and
the patient’s recovery, as well as provide more guidance on how value-based contracts
and price reporting would affect other price regulations, the council said.
In the Medicare Part B program, many specialty drugs are reimbursed in physicians’
offices and hospital outpatient departments based on a 6 % markup
above the average sales price, which creates an incentive to raise costs.

“I highly doubt trade policy reform would make any
meaningful difference,” she said. “The U.S. pays the
highest prices because the market will bear it—until
we figure out how to curb that greed, it will continue.”
The report condemned “free-riding” foreign countries
that force U.S. drug manufacturers to comply with pricing
rules to gain market access. This allows them to undercut
U.S. drug prices and erode manufacturers’ returns.
It also rejected imposing government price-setting on
drug manufacturers, a tactic backed by Democrats, arguing
that “if the United States had adopted the centralized
drug pricing policy in other developed nations 20 years
ago, then the world may not have highly valuable treatments
for diseases that required significant investment.”
But getting other countries to pay “their share” of pharmaceutical
costs is extremely unrealistic, Fox said.
The FDA approved more than 1,000 generic drugs last year, the
highest mark in the history of the agency’s drug approval program.
The FDA has increased competition by expediting reviews
of abbreviated new drug applications where there are limited
approved generics, publishing an off-patent list of branded
drugs without an approved generic and new guidance to improve
communication between manufacturers and the agency.
The White House advisers recommended extending this
strategy to products that are second or third in a class
that have no generics. This could lower prices by providing
quicker entry into monopoly markets, they said.
Rising drug prices have been a focal point of lawmakers,
consumers and others involved in delivering healthcare who
lament the current systems that lacks competition and free
market control. Numerous headlines about drastic price increases
and pharma companies’ system-gaming techniques
to elude competition fueled bipartisan outrage and 100-plus
drug-price related bills. While many ideas have been proposed
to lower drug prices, solutions thus far haven’t stuck.
The Creates Act and FAST Generics Act are two examples targeting
drug prices by trying to close patent loopholes and potentially
saving billions of dollars a year in reduced drug costs.
Per-person spending on prescription drugs covered in
employee-sponsored health plans rose 1.5% in 2017,
less than half the increase in 2016 and the lowest in 24
years that pharmacy benefit manager Express Scripts
has tracked the data, the organization reported Feb. 6.
Generic fill rates increased from 85.1% in 2016 to 86.2% and increased
generic competition helped slow drug prices’ steep ascent,
while spending on specialty drugs was up 11.3%, the lowest
increase Express Scripts has reported. Still, pharmaceutical
products cost more in the U.S. than any developed country.
Health and Human Services Secretary Alex Azar
said Friday he would push ahead with drug pricing
reforms despite pushback from the pharmaceutical
industry.Azar was defending the administration’s
latest, and most aggressive action yet, to target escalating
drug prices in the U.S.
A proposal announced Thursday by President
Trump and Azar would base payments for some drugs
off of lower prices in other countries.
In a white paper, the council
proposed increasing
competition for pharmacy
benefit managers, restricting
drug-reimbursement
under the 340B drug
discount program and
moving Medicare Part B
drug coverage into Medicare
Part D, among other
recommendations.
But these “me too” drugs are likely to enter at similar prices
as their competitors, and the strategy fails to address issues
surrounding pharmaceutical companies gaming the
system through citizen petitions, getting additional exclusivity
periods and evergreen their patents, Fox said.
The council also advocated for increasing competition
among biosimilars, which are more complex and expensive
to make, by speeding up the issuance of final guidelines
on demonstrating biosimilar interchangeability. Experts
have widely touted the benefits of increasing the
speed of interchangeable biosimilars to decrease costs.
Still,to the prior impotant policy recommendations
have been thwarted. The Obama administration had
proposed its own drug policy reforms that were ultimately
quashed by pharma companies and providers.
“The Obama administration had an opportunity with the
ACA and control over the House and Senate and there wasn’t
really anything about drug price controls in there,” said
John Kelliher, managing director of the Berkeley Research
Group. “The problem with drug prices is that it is easy to
complain about but the policy tools to fix it are pretty limited,
and even more limited if you’re not doing some price
control-regime. It leaves you tinkering around the edges.”
Looking ahead, health systems can expect drug prices to increase
by 7.35% from July 1, 2018 through June 30, 2019, driven
by the surging prices of branded, specialty medications,
particularly disease-modifying anti-rheumatic drugs, agents
for multiple sclerosis, oral oncology agents, and multiple
treatments for hepatitis C, according to a recent forecast by
the group purchasing and consulting organization Vizient.
That projection was slightly down from last year’s estimate of
7.61% as some specialty drugs like hepatitis C treatments are
expected to level off and fewer drug price hikes are expected
given the rising public scrutiny.
Health and Human Services Secretary Alex Azar said Friday
he would push ahead with drug pricing reforms despite pushback
from the pharmaceutical industry.
“Finally seeing this system reformed, in fact, is one of the pharmaceutical
industry’s ultimate nightmares,” said Azar, a former
Eli Lily executive, at a Brookings Institution event in Washington.
“I can tell you that because it used to be my job to have
pharmaceutical nightmares.”
“But now we have a president who is definitely not afraid of upsetting
drug companies and isn’t afraid of taking on ostensibly
invincible special interests,” he added.
Azar was defending the administration’s latest, and most ag-
These relatively modest proposals will not
satisfy Democrats who remain fixated on
adopting a single payer system where the
Federal government can set prices, as is
the case in western Europe
22
23

gressive action yet, to target escalating drug prices in the U.S.
A proposal announced Thursday by President Trump and Azar
would base payments for some drugs off of lower prices in other
countries. The policy would only apply to Medicare Part B,
which covers drugs administered in doctors’ offices.
The administration is “not turning back” from its efforts to
lower drug prices, Azar said. “We will put American patients
first by reforming how Part B pays for drugs, and this reference
pricing model will happen.”
PhRMA — the deep-pocked trade group representing
pharmaceutical companies in the U.S. — came out swinging
after the announcement, arguing it would “jeopardize
access to medicines.”
Azar responded Friday to that criticism, saying “something
has to change” and that the administration’s model would increase
patient access.
“This is widely understood across the health care spectrum,
and it’s been a long time coming,” he said. “The only thing
standing in the way is the one special interest that has benefited
from this program far out of proportion to any other actor
for the last 15 years: the pharmaceutical industry.”
A study released by the administration Thursday says Medicare
pays 80 percent more than other advanced industrial
countries for some of the most expensive medicines administered
at doctors’ offices.
Azar argued that over the next five years, that percentage
would drop to 26 percent, and the U.S. would save $17 billion,
under the administration’s plan.
Azar said it’s unlikely pharmaceutical companies would
stop selling drugs to the U.S., especially since under
the proposal it would still pay more for those drugs
than other countries.
“Not only are drug companies never going to walk
away from the world’s largest payer for prescription
drugs, they’re certainly not going to walk away
while they’re still getting paid a quarter more than
they are elsewhere.”
The administration will accept public comments before implementing
its proposal, which doesn’t require congressional
approval. It’s certain to face strong headwinds from the pharmaceutical
industry, which is on track to spend more on lobbying
this year than it has in recent history.
Trump’s Drug Pricing Reform Proposals May Be Politically
Tepid But Are Sensible Policy
With HHS Secretary (and former Eli Lilly executive) Alex Azar
by his side, President Trump stepped to the podium in the gloriously
sunny White House Rose Garden yesterday afternoon
and promised that “we are going to see prices go down, and
it will be a beautiful thing.” Based upon the actual blueprint,
which remains a work in progress, be the case. But if it proves
to be so, it will not be because the administration is wielding
the metaphorical meat cleaver to cut prices by government
edict and risk gutting our biomedical innovation engine.
Instead – and, it must be said, uncharacteristic of Trump – he
appears to have listened to sober, serious, well informed folks
like Azar and FDA Commissioner Scott Gottlieb, and opted to
endorse a series of incremental policy and market-based reforms
that will eliminate many of the existing incentives that
compel drug manufacturers to push list prices ever higher.
As has been noted by market watchers, industry analysts and
healthcare sector investors breathed a collective sigh of relief.
They had feared a draconian proposal that might have led
to the re-importation of pharmaceuticals shipped out of the
country for marketing in Canada, or allowed the Federal government
to negotiate directly with manufacturers under the
Medicare Part D outpatient prescription drug program.
But Trump did not go there.
Notably, the administration outlined what it regards as incentives
for irresponsible pricing and business practices that hurt
American consumers and drain government coffers. ⚛
"These relatively modest proposals will not
satisfy Democrats who remain fixated on
White House outlines reforms to lower drug prices
The White House’s Council of Economic Advisers
adopting a single payer
on Friday
system
recommended
where
easing government
the
regulations to lower drug and reinforcing
Federal government can set prices, as is the
the Food and Drug Administration’s push to spur
competition through expedited approvals.
case in western Europe"
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Chronicles
Diabeties-A New Cure
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On January 15, 2011, in partnership with Rick
Warren from Saddleback Church in Orange County
and two other doctors, launched The Daniel
Plan – a social experiment to learn if community
support was more effective than medication or
conventional medical care for treating and reversing
disease and creating health.
Our Global Obesity and Diabetes Epidemic
One in two Americans has pre-diabetes or diabetes—that
is every other person in America. Twenty five percent of
diabetics and ninety percent of pre-diabetics are not diagnosed.
Caring for them will cost $3.4 trillion over the next
10 years. One in three Medicare dollars is spent on treating
diabetes.
This is a global problem. From 1983 to 2011 world-wide diabetes
prevalence increased from 35 million to 366 million
and is projected to grow to 552 million in 2030. Ninety five
percent of diabetes is lifestyle induced type 2 diabetes. The
world’s best-selling blockbuster diabetes drug, Avandia, has
killed nearly 200,000 people from heart attacks since it was
introduced in 1999 – the very disease that kills most diabetics.
The solution to our diabetes epidemic will not come
from within the health care system. It will not come at
the end of a pill bottle or the blade of a scalpel. We cannot
bypass the fact that this is a lifestyle disease and cannot be
solved by better or more medication.
Doctors graduate medical school knowing more about
treating malaria than treating obesity — or what I call DI-
ABESITY – that now accounts for most the patients they
see. We need to rethink medicine and rethink health care.
When the collective cost of diabesity related disease – heart
disease, cancer, dementia, strokes, infertility, depression
and more is accounted for, it is the single biggest contributor
to our health care costs and our national debt. Seventy
percent of our federal budget is spent on Medicaid, Medicare
and Social Security. It is unsustainable.
In the face of those seemingly insurmountable statistics,
I had an insight after working with Paul Farmer in Haiti
where he built the model of accompaniment – community
health workers and peer support that created the conditions
that led to health.
The insight was this – that the community could be the
cure.
I realized that getting healthy is a team sport!
The Daniel Plan
The Daniel Plan is a wellness program delivered through
small groups in the church. Rick Warren’s church of 30,000
met every week in 5,000 small groups. That was the secret
sauce. The program is named after biblical story of Daniel
and his small group of men who refused to consume royal
food and wine. By eating vegetables and water, “they looked
healthier and better nourished than any of the young men
who ate the royal food,” according to Daniel 1:15.
In the first month 15,000 people signed up, and over the
last year they have lost an estimated 250,000 pounds – or
the equivalent of 10 tractor-trailer trucks loaded with soda.
Over 6,000 people spontaneously joined from around
the country. There have been over half a million visits to
our Daniel Plan website from 189 countries. Hundreds of
churches from around the country have called to participate
and build programs for their own churches. Rick cast
a vision to scale this through faith based communities to 1
billion people.
The results appear to be more effective than conventional
medical care for chronic disease. The program is based
on functional medicine – a way of treating chronic disease
through lifestyle based systems solutions – not just treating
symptoms. It is the science of creating health, not treating
specific diseases. Disease goes away as a side effect of
creating health. That delivered within small groups via
The Daniel Plan was the lever than moved mountains – of
donuts, ribs, soda and more!
Not only were there estimated weight reductions of 250,000
pounds but also equal reductions in medication use, hospitalizations
and doctors visits. And it was free.
In a survey after 10 months of the program, participants
reported the following:
An average weight loss of 13.5 pounds (and 18
pounds for those who said they followed the
program closely)
72% of those who wanted to lose weight did
53% reported increased energy levels
34% reported better sleep
27% improvement in blood work
20% reported improvement in blood pressure
11% reported reduction in medications
31% reported improvement in mood
Those who did the plan together lost twice as much weight
as those who did it alone.
People like Chiquita Seals lost 125 pounds and Kendall Rock
reversed his diabetes. Others got off their insulin, heart.
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