“Do No Harm” in the effort to lower drug costs

As we enter a new decade, advances in medicine hold the promise for a brighter future in the battle against deadly diseases like cancer.  Advances in immunotherapy and targeted gene therapy, for example, present opportunities not even imagined just few years ago.  The challenge for politicians and policy makers is to keep these life-saving advancements coming, while at the same time keeping them affordable for patients.

Getting this balance right is especially important to the large population of Seniors we have in Arizona.

Just 15 years ago a Republican Congress and President modernized Medicare by creating a prescription drug benefit called Medicare Part D.  Unlike other parts of Medicare, Part D was designed on the free-market principles of plan competition and senior choice.  Recognizing that one size does not fit all, every year Seniors have a choice of a variety of plans who compete vigorously for their business.  In order to keep their premiums low and attract Seniors to sign up, plans have a strong incentive to drive a hard bargain with drug manufacturers to keep prices down.

Affordable Drugs

It comes as no surprise to conservatives, that Part D’s free-market model has worked.  When the legislation was passed, the Congressional Budget Office estimated both the cost of the program to Medicare and the average monthly premium a Senior would pay, for the first 10 years of the program.  The actual results were remarkable. 

Medicare spending was 35-40% less than predicted and average monthly premiums projected to be $55 or more in 2016 are in fact only $32.70 in 2020 and that is a slight decrease from 2019.  In addition to these financial measure of success, Part D maintains a Senior Satisfaction Rate in excess of 90%, unheard of for most government programs.

Despite this success, big government advocates like Nancy Pelosi want undermine Medicare Part D and its sister program Medicare Advantage, by importing government price controls from socialist countries.  What is known as an International Pricing Index (IPI) is included in her signature drug pricing legislation which passed the House of Representatives last December. 

President Trump has correctly pointed out that many advanced economies around the world which have socialist health care systems are not paying their fair share of R&D costs for new drugs.  They are freeloading on American consumers.  But the answer is to stop these unfair trade practices, not import their socialist price fixing to the US!

Socialist health systems hold down cost by rationing drugs.  They either wait a long time to make new drugs available to their people, or they are never available.  Writing in Forbes in February 2020 author Doug Schoen points out that “roughly 96% of new cancer medicines are made available in the United States, while the 16 countries used in the International Pricing Index only have 55% of new cancer medicines.  Further, patients in these 16 countries also receive these medications on average 17 months after release, whereas in the United States, patients have almost immediate access to new cancer medicines following FDA approval”.

These cold statistics translate into patient’s lives.  An HIS Markit study published in 2018 “Comparing Health Outcome Due to Drug Access: A Model in Non-Small Cell Lung Cancer,” concludes that half of the gains in life expectancy we have made in fighting lung cancer, the number one cancer killer worldwide, would have been lost if the rationing policies found in Australia, Canada, France, South Korea and the United Kingdom were replicated in the US.”

Government price controls on drugs are not the answer.  But neither is doing nothing.  Fortunately, Senator Mike Crapo (R-Idaho) and Congressman Greg Walden (R-Oregon 2) have introduced legislation to help. 

Their legislation, S. 3129 and H.R. 19, preserve the free-market competition which has worked so well in both Medicare Part D and Medicare Advantage, but directs that more of the savings from negotiations with drug manufacturers flow directly to the consumer at the pharmacy counter in the form of immediate discounts.  They also cap the annual out-of-pocket spending Seniors must pay for prescription drugs. 

The legislation also takes steps to reduce the freeloading of other developed nations on our R&D and streamlines coordination between the Food and Drug Administration (FDA) and Medicare to insure that new treatment reach Seniors as quickly as possible.

Doctors take an oath, “First, do no harm.”  That’s good advice for politicians and policy makers as well.  Taking steps to lower drug costs to Seniors is important.  But we must do it the right way or we will harm those we are trying to help.

Arizona Conservatives bash FDA for regulatory assault on e-cigarettes

Arizona’s own Goldwater institute has joined a number of center-right leaders in urging Trump’s FDA to stop government overreach into personal health decisions. The coalition is calling a proposed crackdown on e-cigarettes a regulatory assault. Conservative groups nationwide are calling on President Trump to halt FDA commissioner Gottlieb’s panic driven regulatory action.

“FDA Commissioner Scott Gottlieb’s effort to curb the $6.6 billion electronic cigarette industry and an even larger reduced risk tobacco alternatives market is inconsistent with your clearly articulated deregulatory objectives and will destroy jobs, limit consumer freedoms, and harm public health.  

This week, a Washington Post op-ed bashed the FDA over its recent crackdown on vaping and e cigarettes

As the column noted, “Last week, a large trial published in the New England Journal of Medicine and led by British researchers showed people trying to quit cigarettes were almost twice as likely to succeed if they used e-cigarettes instead of conventional nicotine-replacement therapies such as patches and gum.”

Nevertheless, FDA commissioner Gottlieb shows no sign of backing down. In an interview Sunday, he said that while the FDA supports the role of e-cigarettes in helping adults quit smoking, “it’s now clear that widespread and sometimes reckless marketing of these products has come at the expense of addicting a new generation of kids on tobacco.”

This is irresponsible at best, and completely inaccurate. Vaping technology is not marketed to kids, and is a great resource for adults who wish to quit smoking.

The letter to President Trump was signed by more than a dozen conservative groups, including Arizona’s Goldwater Institute, ALEC action, Americans for Tax Reform among others. A copy of the letter can be read here.

9th Circuit Court Puts Hold on Arizona Law: Disregards District Court

By Joanne Moudy

There was a time when states had rights and could count on the sovereignty of their own state constitutions and laws.  But with the ever-growing overreach of our tyrannical federal government and liberal judges, that time is long past.  In fact today, as fast as states pass laws to distance themselves from the insanity of unlawful federal mandates and regulations, higher court decisions reverse those efforts.

So it doesn’t come as a huge shock that the 9th Circuit justices issued an injunction against Arizona’s law pertaining to abortion drugs, but it does seem odd that the justices don’t feel obligated to follow federal FDA guidelines on pharmaceutical issues.  I guess all those inconvenient rules are meant to be bent, twisted, and broken as often as necessary to further the socialist agenda.

In 2012, HB 2036 was passed by the Arizona State Legislature and signed into law by Governor Jan Brewer.  The law, which took effect in April, 2014, was an important step in tightening regulations on abortion providers to ensure that the medical care they provide to pregnant women is in compliance with federal guidelines and not based upon what’s best for the clinic’s profit margin.

But no sooner had the law taken effect than Planned Parenthood and the Tucson Women’s Center filed suit seeking an injunction against it on the grounds that it puts an “undue burden” on women seeking an abortion.  However, U.S. District Court Judge David Bury refused to grant an injunction and rejected their argument, stating the law was put in place to protect women from “dangerous and potentially deadly ‘off-label’ uses” of abortion drugs.

But even before Judge Bury could rule on the legal issues, the 9th Circuit Court of Appeals slammed down their collective heavy-handed gavel on Tuesday and granted a temporary stay.  Apparently they have no respect for the lower court’s legal process or deliberation, because they stepped right in and took the case away from the District Court.

ru4864

image credit: LifeNews

The absurdity is that the portion of the law in question simply mandates that the abortifacient drug, RU-486, Mifeprex, be used only per the guidelines of the United States Food and Drug Administration (FDA).  Seems pretty straight forward to most physicians, but Planned Parenthood wants permission to do something no other doctor or hospital in the country can do.  They want to operate outside government rules and collect your tax dollars while doing it.

According to the Center for Arizona Policy, when the FDA approved RU-486, it did so under Subpart H, a much more restrictive section of the FDA’s rules specifically set aside for potentially dangerous drugs.  Out of almost 1800 new drug applications approved by the FDA between 1992 and 2011, only 70 were approved under Subpart H.

The drug itself comes with precise prescribing information, labeled uses, and a lengthy warning list, and the licensing under Subpart H simply reinforced the manufacturer’s intentions.  Clearly, the FDA believed the side effects of using the drug “off-label” – hemorrhage, ruptured uterus, sepsis and/or cardiac arrest – constituted serious threats to the patient.

RU-486 blocks the hormone progesterone, thereby causing the fetus to be starved of all nutrients, die, and detach from the uterine wall.  The manufacturer intended for the drug to be used up until 49 days of gestational age, and not beyond.

“On-label” dosing is for the woman to take 600 milligrams of RU-486 orally at the clinic and then return two days later and take 400 micrograms of Misoprostal in the presence of a licensed healthcare provider.  Misoprostal causes the uterus to contract and expel the dead fetus and any remaining contents.  The idea is that the woman be observed while she expels her uterine contents, on the off chance something goes wrong (other than the obvious).

The FDA also recommends that the woman return to the clinic a third time for a follow-up exam to ensure there are no complications (fragments of the baby still inside, etc.) from the chemical abortion.

As a side note, Arizona State Law requires that all women seeking an abortion must be given a counseling session, followed by a 24-hour waiting period before proceeding with an abortion.  That includes ingesting abortifacient drugs.

But Planned Parenthood wants to skip the initial counseling session and the 24-hour waiting period.  They also want to be able to give the RU-486 up to 63 days gestational age, when the fetus is significantly larger and more difficult to expel.

Planned Parenthood’s normal modus operandi is to do a cursory ‘exam’, convince the woman to swallow the RU-486 and then send her home with instructions to take the second drug at home.  As a matter of fact, they frequently advise their clients to not return to the clinic for a recheck after the abortion and bleeding are finished.

And here’s the rub.  Planned Parenthood dispenses RU-486 in one-third the normal dose (200 milligrams), claiming it’s cheaper and safer for the woman.  Naturally it’s cheaper – it’s one-third the dose.  What Planned Parenthood forgets to mention is that the lower dose also means the baby dies more slowly.

What they also fail to mention is that the dose of the second drug, Misoprostal, – the one the woman will take at home, is double.  So when the uterus starts to violently contract and/or the woman is bleeding heavily, she will be alone, unsupervised and without benefit of medical care.

Since medication abortions now account for 41 percent of all first-trimester abortions performed at Planned Parenthood clinics nationwide, they have a vested interest in making certain they can do as they please, regardless of the risk to the mother.

At least fifteen deaths have been attributed to RU-486 since it was licensed and many more women have had complications serious enough to warrant total hysterectomies.  Regardless of Planned Parenthood’s propaganda, RU-486 is not a benign drug without risk.

Aside from the Court’s reaction, it’s also interesting to see how some of the Arizona candidates from two key races responded.

Chuck Wooten, GOP candidate, U.S. Congress, AZ D-2 said, “Abortion is tragic enough without coupling it with reckless, unsafe “medical” practices.  The 9th Circuit Court of Appeals ruling categorically invalidates and marginalizes scientific, FDA precautions that are designed to protect the health of the women involved in ingesting abortifacient drugs.  As Americans have watched for far too long, liberal judges, particularly in the 9th Circuit are legislating from the bench at the peril of women, many of whom are already in a crisis situation.”

According to the Arizona Republic, as of May 27th, his opponent in the primary, Martha McSally, had no comment this issue, and the democratic incumbent, Ron Barber, ardently supports Planned Parenthood and abortion on demand.

Wendy Rogers, GOP Candidate, U.S. Congress, AZ D-9 told the Republic, “I’m 100 percent pro-life, because life is a precious gift from God.  We need to help young women understand they have options beyond abortion.”

Although her GOP primary opponent, Andrew Walter, did not respond to the Arizona Republic, Walter is on record as being Pro-life.  The democratic incumbent Kyrsten Sinema supports abortion on demand, up to full-term.

Considering that the 5th and 6th Circuit Courts of Appeals have already upheld similar laws in states within their jurisdictions, it seems likely that this battle isn’t over.  The tragedy is that one case at a time, the higher federal courts are rendering states impotent to enforce their own laws and stomping on their unique sovereignty.