Risky Drugs Are Being Marketed to People With Mental Health Issues

"There is egregious overmedication with very dangerous antipsychotics for people who don't need them."

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Aug 15 2017, 5:00pm

America's healthcare system has been making headlines recently due to the floundering efforts of conservative Congressmen to create anything close to an adequate replacement for Affordable Care Act, otherwise known as Obamacare. Although the most recent "skinny" iteration of the so-called GOP's "repeal-and-replace" bills was shot down in the Senate, McCain and other Republicans said they still think it's possible to get a new replacement healthcare bill on the President's desk before the end of the year.

The far-reaching effects of the previous versions of the GOP healthcare initiative have been covered ad nauseum, but one of the issues that has received relatively less attention is how the GOP's healthcare bill would affect some of the most vulnerable members of the population: those with mental illnesses.

This is partly the focus of journalist Art Levine's new book, Mental Health, Inc., out today. The book is a searing indictment of the sorry state of the American mental health care system as seen from the perspective of those who have been victimized by it. In it, Levine explores the needless tragedies wrought by overmedication with antipsychotics for America's veterans, elderly, and those with severe mental illnesses like schizophrenia, and why almost nothing is being done about it.

Ultimately, Levine argues that that a combination of pharmaceutical industry corruption, academic collusion, and lack of government oversight have combined to create a perfect storm of mental health maleficence. Tonic spoke with the author ahead of the book release to learn more about how Big Pharma created a mental health crisis.

How would you characterize the current state of mental health care in the US right now?
In my view it's a national disaster and a national disgrace that hasn't been fully addressed. The main thrust of arguments from many mental health reformers is there needs to be more access, more funds, and more practitioners. All of that is true, particularly in rural areas. But what isn't being addressed in any meaningful way by any national reform organizations or government agencies is what I call the epidemic of mental and behavioral health care malpractice. There is egregious overmedication with very dangerous antipsychotics for people who don't need them. That issue has been left off the table.

What role does the pharmaceutical industry play in this?
What used to happen decades ago was academic researchers would be doing a lot of the pharmaceutical research. Now much of the research is being done by drug companies. What is missing is meaningful oversight and regulation. There is an existing law that is not enforced regarding Medicaid and Medicare spending for off-label uses of medication, which means it is not approved for certain uses by the FDA. It is legal for a physician to prescribe off-label uses for a medication, but drug companies get in trouble for marketing medications for off-label uses. It's a very sophisticated thing, how drug companies do this. Essentially what they do is they give brands to academic researchers who then go about doing poorly designed studies that get published in peer reviewed, respected medical journals arguing for the value of these drugs for these off-label purposes. They're promoting that. They also have illegal marketing campaigns to the health care providers.

The whole system is devised to incentivize and wink at any kind of off-label marketing. On the other hand, all the drug companies are getting their agendas met because the federal government and state governments continue to pay for completely fraudulent, off-label uses of sometimes risky drugs like anti-psychotics through Medicare and Medicaid.


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Do you have any specific examples?
One of the first companies to be exposed for this illegal marketing was Eli Lilly. They had an antipsychotic drug called Zyprexa. There was a Justice Department settlement based on whistleblowers for $1.4 billion for off-label promotion. Eli Lilly had marketing plans for primary care doctors and for nursing home pharmacies and staff with this catchy slogan: Five at Five. They urged nursing homes to administer 5mg of Zyprexa at 5pm to induce sleep in patients. That was completely improper. The problem with the way it works now is doctors and nursing homes and all healthcare providers can provide any drug outside of a narcotic or controlled substance to any patient for any reason. That is completely permitted. What is illegal is marketing those off-label uses.

It sounds like the government is going after pharmaceutical companies, but you're saying laws aren't being enforced. Can you explain that?
The Justice Department pursued drug companies, at least under Obama and Clinton. So over the last 25 years, drug companies have paid $35 billion in fines for all sorts of illegal marketing and promotion for improper uses of the drugs and hiding side effects. But that's chump change compared to $700 billion these same companies have made over 25 years.

For instance, at its height, AstraZeneca's antipsychotic drug Seroquel got $5 billion a year in revenue. If you get to make billions each year for seventeen years in a row, who cares if down the line there's a Justice Department settlement and you have to pay a half a billion dollars? That's what happened in 2010 to AstraZeneca. It's chump change, and after these drug companies are caught red-handed, they agree to a settlement, and generally don't acknowledge wrongdoing. In some cases they do admit to some minor crimes, but executives are almost never personally convicted of crimes and no one goes to prison. After all that happens, there are corporate integrity agreements, but the Health and Human Services Department never enforces them so they're completely meaningless. It's a joke. Over decades there've been maybe 2 or 3 minor enforcement actions for the drug companies for violating the earlier corporate integrity agreements.

As you point out in your book, the marketing of these off-label uses for antipsychotics has led to hundreds of needless deaths. Why don't you think this is a bigger issue in the US?
It has to do with shame and stigma in part. People who have mental illness often want to keep it quiet and there's still a view that it's a moral failure, rather than an illness. Even though there are laws that have been passed, there's really no parity in practice. It's an illness, but it can be addressed if you're using proactive treatments.

How would the proposed GOP health care bills affect mental health care in the US?
Any version is a nightmare. A disaster. It will undoubtedly lead to deaths. There are at least 4 million people because of Obamacare and the Medicaid expansion with mental health and substance abuse disorders who never were insured before. They now have coverage. Having access and coverage you have a better chance of improving your life. As a country we need to keep two different concepts in our head: Quality needs to be improved and overmedication needs to not be paid for or encouraged.

How would you advocate to improve the mental health care of people who are already receiving it?
Use evidence-based practices that already exist. One of the falsehoods of mental illness is that once you become mentally ill, it's hopeless and nothing can be done. We'll just give you some drugs and hopefully you won't do anything dangerous to yourself or others. But there are very solid programs, the problem is they're not supported by the federal government. Things like supported employment, which helps people with the most serious mental illnesses get jobs. The program involves a job coach who works with a person with mental illness to get a job that means something to them while they don't necessarily work a full week so they can retain all their benefits. It helps them get back to work which has an unbelievably transformative effect. That program requires some outlay of money by the government, but it will save enormous amounts of money in the long term by avoiding the outrageous amount of money we spend on prisoners and emergency room fees that aren't reimbursed by people who end up there. These are common sense measures but there's no meaningful support for them despite the evidence.

We also need to aggressively educate people on proper uses of medication and to stop paying for improper medication uses. In many ways the theme of my book is the first part of the Hippocratic oath: do no harm. The second theme of the book is do what works. Various programs have been shown to make enormous differences in people's lives, but less than 2 percent of people with serious mental illness have access to these programs. So we are reinforcing decade after decade tragedy, death, waste of money. It's just unconscionable that this is happening.

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