September 21, 2014

Not all agree that Missouri should monitor prescription drugs

As a New York Times article highlighted this week, Missouri is the only state without a prescription drug monitoring program (PDMP), but not everyone agrees on how big a problem that is.

Senator Claire McCaskill

Senator Claire McCaskill

Senator Claire McCaskill (D) calls it embarrassing that Missouri doesn’t maintain a database of the prescription drugs Missourians buy, a database that doctors, hospitals, pharmacists and others could access. Proponents say such a program could help identify individuals who “doctor shop,” and stockpile prescription medications to sell illegally.

She says Missouri has now become, “a Mecca for opiate dealers all over the country. Every opiate dealer in the country knows they can come to Missouri and avoid detection.”

Some opponents of such a program say the database it would create could be abused or hacked into.

Representative Kevin Engler (R-Farmington) says those arguments are weakened by the lack of problems in the 49 states that have a monitoring program.

“You’ve had years of experience from these other states that have not resulted in a breach of security on the database, or [a registry] hasn’t been shown to be the way police are going after people or going after doctors,” says Engler. “It’s simply used to try to stop, at the start of the process, the abuse of legal drugs.”

Representative Kevin Engler (left) and Senator Rob Schaaf (right)

Representative Kevin Engler (left) and Senator Rob Schaaf (right)

However, Senator Rob Schaaf (R-St. Joseph) says other states have had problems.

“The database has been hacked in five states; in Florida, Virginia, Colorado, Utah and Washington,” says Schaaf.

Schaaf also points to stories of abuse of a database, such as that of a police officer in Utah who used the registry to go into a couple’s home and take their prescription pills, and of a Utah man who says immediately after his wife died of cancer, police showed up at his home asking to confiscate her pain medication.

Schaaf says there are also questions about the effectiveness of a monitoring program. He says studies of monitoring programs, “do not consistently show that they reduce deaths from opioid overdose, and at least one shows that when the PDMP is enacted, heroin use actually increases.”

Schaaf thinks a database would violate Missourians’ liberty, and says they should ask themselves whether they want the government to know what prescriptions they are taking. Still, he’s proposed versions of a registry and says he’s willing to compromise.

McCaskill believes a registry will fight prescription drug abuse, and hopes state lawmakers “wake up” about the issue soon.

“We’re killing Missourians by not doing this database,” says McCaskill.

Missouri Senators discuss rulings on federal health care subsidies

It is likely the U.S. Supreme Court will decide whether subsidies for insurance coverage under the federal healthcare reform law will continue to be available, after conflicting federal appeals court rulings about them this week.

Senator Claire McCaskill (D-MO)

Senator Claire McCaskill (D-MO)

One ruling upholds subsidies for insurance purchased on the federal exchange, one says the law only provides them for insurance purchased on state exchanges.

The case carries extra meaning in Missouri, where the Republican-led legislature opted not to create a state exchange.

Senator Claire McCaskill (D) believes in the end, the subsidies will be upheld.

“We’ve had a number of court decisions on this issue and most of them have said that the subsidies are perfectly fine in the federal exchanges, so I think ultimately that position will prevail in the courts,” says McCaskill. “It has been the dominant decision in the courts that have considered it.”

The other option would be for Congress to change the law to clarify that those subsidies are OK, but Senator McCaskill says that is unlikely.

“It would be great to fix it along with other things that we’d like to fix in the health care bill, unfortunately it’s being wielded as strictly a political weapon by the Republican party right now,” says McCaskill. “They will not come to the table and fix things that need to be fixed because they think it diminishes their ability to win elections around this issue.”

Senator Roy Blunt (R-MO)

Senator Roy Blunt (R-MO)

Senator Roy Blunt (R) says the conflicting rulings are the result of courts trying to sort out a law that didn’t go to conference between the two chambers.

“The law was poorly written, it was poorly structured, it was crammed down the throats of the minority in both the House and the Senate,” says Blunt.

Discussing the case potentially reaching the Supreme Court, Blunt tells Missourinet affiliate KZRG in Joplin, “Ultimately this gives John Roberts maybe a chance to redeem himself and look at this law one more time, and decide it’s really not the best thing for the country and was done in the worst possible way.”

Blunt refers to U.S. Supreme Court Chief Justice John Roberts, who delivered the majority opinion when the Court upheld the constitutionality of the “Affordable Care Act.” Roberts, an appointee of President George W. Bush, has been heavily criticized by conservatives for voting to uphold that law.

Backers, critics argue significance of Missouri’s new ‘right to try’ law

Next month, Missouri will have a “right to try” law in place that aims to allow terminally ill patients who have exhausted conventional treatments to seek the use of drugs, devices and products that haven’t gone all the way through the federal Food and Drug Administration’s testing process.

John DiPersio, MD, PhD (left) and Show-Me Institute analyst Patrick Ishmael

John DiPersio, MD, PhD (left) and Show-Me Institute analyst Patrick Ishmael

Governor Jay Nixon (D) signed legislation on Monday to make Missouri the third state to enact such a law, to give patients and their doctors the opportunity to try so-called “investigational” drugs if the makers of those drugs agree.

Proponents of the measure like Show-Me Institute analyst Patrick Ishmael say it will mean a lot to patients.

“I think they’re going to find this legislation as being very helpful to them, being very hopeful for their families,” says Ishmael, “and at the end of the day it provides them an opportunity to pursue treatment and care that before, the state may have been able to step in and try to prevent.”

See the legislation, HB 1685

The bill has critics, however, who say it won’t actually do anything.

“The problem is there’s this thing called the FDA,” says Doctor John DiPersio, Deputy Director of the Siteman Cancer Center in St. Louis and Chief of the Division of Oncology at Washington University in St. Louis.

DiPersio says a mechanism for giving patients access to investigational drugs already exists. He says no matter how the new law reads, the administration to a patient of a drug still under development without FDA approval is illegal.

“If you gave an investigational drug and the FDA found out about it … outside of a clinical trial, outside of their proper mechanism, then it could be potentially catastrophic for the patient, the physician and the institution,” says DiPersio.

DiPersio says it is unlikely pharmaceutical manufacturers would risk development of new drugs by giving them to patients under the terms of the “right to try” law.

“You can’t just give your drug to everybody in the country that wants it and not be in a position to actually, rigorously follow those patients,” says DiPersio, “because if something bad happens then it could undermine the development of the drug, number one. Number two is that there are liability issues.”

HB 1685 was sponsored by Representative Jim Neely (R-Cameron)

Proponents counter that one company, Neuralstem Inc, has expressed interest in making available experimental treatments for Amyotrophic Lateral Sclerosis (ALS, otherwise known as Lou Gehrig’s Disease), under Colorado’s right to try law.

Still, DiPersio says allowing such access to new drugs not only threatens their development, but he criticizes the bill for allowing drug companies to require patients receiving an experimental drug, product or device, to pay for them.

“Under the current practices you’d have to get FDA to approve it, it actually reduces or limits the liability of the company providing it, insurance companies have to pay for the standard of care associated with it and any complications because it’s FDA approved,” says DiPersio, “But now, you’re telling me that the companies can actually ask for a payment for an investigational drug for which there is no known cost associated with it, so they could make up a cost.”

Ishmael says there is no way to be sure what drug manufacturers are going to do.

“Do we know the future about what the FDA will do, about what drug companies will do? This is a new innovation in the law, and really it’s a de-regulation where the state is getting out of the way,” says Ishmael.

Ishmael says he has no doubt the legislation will make a difference.

“There is something to be said for hope. There is something to be said for opportunity,” says Ishmael, “and I think the patients who are in a terminal situation deserve the hope and the opportunity of making sure that the state is not going to stand in their way when they seek this sort of experimental medication.”

The law becomes effective August 28.

St. Louis VA whistleblower tells congressional committee about retaliation (AUDIO)

A St. Louis psychiatrist has told a Congressional committee how the Veterans Administration retaliated against him when he reported on distressing service to veterans.

Doctor Jose Mathews, the chief of psychiatry for the St. Louis VA Health Care System is a whistleblower, one of four to talk to the committee. He says he saw psychiatrists treating patients for an average of three-and–half hours a day. He also learned sixty percent of veterans who sought treatment gave up after being put off or poorly-treated.

AUDIO: Mathews :07

He says the hospital administration struck back when he complained by assigning him to a filing job.

AUDIO: Mathews :26

Mathews says he was told he was being investigated for creating a hostile work environment. Although he retains his title, he says, VA officials have taken away all of his administrative duties.

If there was one thing he’d change with the VA, he says, it would be creation of trustworthy data. But right now, says Mathews paraphrasing Mark Twain, “there are lies, there are damn lies, and there are VA statistics.”

AUDIO: Mathews :12

A top official with the VA has called the testimony “disheartening” and says it shows again the system is broken.

Law Professor: Hobby Lobby ruling favors ‘religious liberty,’ ‘personal freedom’

The chief counsel representing the family that owns the Hobby Lobby chain of craft stores is an Associate Professor of Law at the University of Missouri, Josh Hawley.

Associate Professor of Law at the University of Missouri, Josh Hawley

Associate Professor of Law at the University of Missouri, Josh Hawley

The U.S. Supreme Court has ruled in favor of that family, the David Green Family of Oklahoma City, who argued that Hobby Lobby should not have to provide insurance coverage for four types of birth control to its employees. The family says having to provide coverage for those four types of contraceptives would violate their religious objection to abortion.

“I would say that this is a decision about religious liberty and personal freedom,” says Hale, “and it comes down to, ‘Can Americans form their own their own religious and moral convictions without the government interfering, and can Americans practice those convictions in the workplace and everywhere?’ and the answer to that question is yes they can.”

Hawley says the ruling makes clear that the 1993 Religious Freedom Restoration Act applies to the owners of family owned corporations. He thinks it’s not likely that other types of corporations would seek such a ruling.

“The majority (of the Court) said, and I think they’re right, that it’s implausible that a large, publicly traded corporation would bring one of these suits just because you’d have to get buy-in from lots and lots of shareholders and conglomerates who hold shares.”
Critics argue that the ruling allows the owners of such a corporation to interfere in the personal health decisions of its female employees. Hawley says the case was never about access to contraception.

“Access to all forms of contraception remains one hundred percent legal, one hundred percent available,” says Hawley. “What the Court emphasized over and over again in its opinion today is that there are other means, the government has other means to deliver or make available these four disputed forms of contraception to the female employees who want it at no cost to the female employees … there just isn’t any burden here on female employees.”

One of the findings of the Court was that the fines the Green family had faced for not providing the coverage in question were to have been particularly steep, “which is one of the reasons why, the Supreme Court said, that the government had indeed substantially burdened the Greens’ faith,” says Hawley.

“The Greens were facing $475-million in fines every year if they failed to comply with this contraceptive mandate, so that was a very substantial burden, indeed,” Hawley says. “That is one of the reasons, again, that the Court said you just cannot impose those kinds of burdens on people of faith unless you can show, ‘you’ being the government, that you have a very compelling interest, and the government couldn’t show that.”

AUDIO:  Hear the full interview with Josh Hawley, 10:06