Los Angeles Time - 08.08.2019

LATIMES.COM/OPINION THURSDAY, AUGUST 8, 2019A

OP-ED

I

f you believe thatthe fed-
eral government and the
pharmaceutical manufactur-
ers are effectively working to-
gether to protect patients
from unsafe drugs, you might want
to consider a trove of records re-
leased in an Ohio court case last
month.
The documents were unsealed,
over the objections of the federal
government and drug companies,
in a landmark, multi-district opi-
oid lawsuit, and they give new in-
sight into an unparalleled epidem-
ic. The first disclosures came in
mid-July, when the Sixth Circuit
Court of Appeals released previ-
ously unavailable information con-
tained in a Drug Enforcement Ad-
ministration database known as
ARCOS. It revealed that between
2006 and 2012, some 76 billion opi-
oid pills were distributed in the
United States — more than 200
pills for every man, woman and
child.

A few days later, more docu-

ments in the case were released,

and they painted a damning pic-

ture of the tension between drug

company profits and patient safety

during the time opioid sales were

climbing dramatically. In one 2009

exchange, a pharmaceutical com-

pany representative emailed a col-

league at another company to alert

him to a pill shipment. “Keep ’em

comin’!” was the response. “Flyin’

out of there. It’s like people are ad-

dicted to these things or some-

thing. Oh, wait, people are.”

And where were federal regula-

tors while all those opioids were fly-

ing off shelves? The DEA filed a

number of civil actions against

drug distributors for failing to re-

port suspicious opiate orders, col-

lecting some $500 million in fines,

according to the Washington Post.

But as the opioid epidemic has

made blatantly clear, the federal

bureaucracy is simply not up to the

task of adequately monitoring and

controlling dangerous pharma-

ceuticals.

The failings are at every point in

the system, starting with drug ap-

provals. But we believe there is a

particularly serious problem with

the mechanisms for identifying,

monitoring and disseminating in-

formation about issues with a drug

after its release.

Once a drug is approved for

market, the FDA relies on an infor-

mal and ineffective system of case

reports and citizens’ petitions to

alert it to problems and adverse

events. In the past, case reports,

submitted to medical journals by

physicians, served as an important

mechanism for detailing drug tox-

icity. But today, because of changes

to editorial guidelines, peer-re-

viewed journals rarely accept such

reports for publication.

Citizens’ petitions, in which any

citizen can petition the FDA to re-

port adverse drug effects, are in-

tended to be another check. But

the petition process is cumber-

some, and they are rarely granted.

Of the 1,915 Citizens Petitions filed

in the 12-year period between 2001

and 2013, a total of 13 were granted.

Many go unanswered altogether.

That was the case with a citizen’s

petition filed by then-Connecticut

Atty. Gen. Richard Blumenthal in

2004 requesting issuance of a warn-

ing with regard to opioids. He re-

ceived no answer until he filed suit

demanding an agency response.

A good starting point for re-

forming the system would be in-

creased transparency about drugs

already recognized as particularly

dangerous. These drugs, currently

numbering about 70 (including

opioids), carry the FDA’s so-called

“black box warning,” intended to

alert patients and their doctors to

the high risks associated with the

drugs. But that is not enough.

We propose a “black box” data-

base or “registry,” publicly avail-

able and simple to use, that would

contain extensive information

about where, by whom and for

what purpose black box drugs are

prescribed, as well as where and in

what quantities such drugs are be-

ing distributed and sold. Informa-

tion about adverse side effects,

culled from the myriad of govern-

ment databases that now collect

them, would also be consolidated

in an open form and format.

Comprehensive registries simi-

lar to the kind we propose have

been highly successful. The Na-

tional Library of Medicine’s

clinicaltrials.gov, for example, pro-

vides patients and doctors with

comprehensive information about

clinical trials being conducted

around the world.

Drug manufacturers are likely

to argue against a black box data-

base, saying it could give an unfair

advantage to competitors. That

was also the argument made by the

government and pharmaceutical

companies in opposing release of

the ARCOS data in the Ohio law-

suit. But the government’s duty is

to protect its citizens, not the drug

companies.

Is there a chance that the exist-

ence of a black box registry would

decrease the use of those drugs?

Possibly, and that would be a good

thing. Too often black box warn-

ings are seen as meaningless, and

they are counteracted with mar-

keting campaigns that promote

off-label use. If adding more trans-

parency, thought and effort to the

prescription and sale of dangerous

drugs winds up decreasing their

use, that will likely be a beneficial

side effect.

This modest reform does not go

far enough, of course. The criteria

and processes surrounding the ap-

plication of black box warnings

need to be more defined and trans-

parent. And there should also be a

comprehensive revision of regula-

tions pertaining to drug approvals,

monitoring and patient safety in

general. But an accessible data-

base to inform patients about the

very real risks of black box drugs

would be an important first step.

Charles L. Bennettis a

physician and director of the

SmartState Center for Medication

Safety and Efficacy at the

University of South Carolina.

William Kennedy Smithis

a physician and an assistant

professor at the Uniformed Services

University of the Health Sciences.

Eric D. Perakslisis a Rubenstein

Fellow at Duke University and a

lecturer at Harvard Medical School.

How the government failed us on opioids

Patients need far more

transparency from

regulators on drug safety.

By Charles L. Bennett,
William Kennedy Smith
and Eric D. Perakslis

programs are not really that cost-

effective, so why not convert most

of them into grant programs?

A portion of the funds cur-

rently being invested in loans

could also be diverted to expand

federal work-study programs,

which partially fund jobs for stu-

dents with financial need. About

half of the nation’s 3,000 colleges

and universities offered work-

study to more than 100 recipients

last year. The university benefits

by being able to stretch its work-

force dollars while students bene-

fit financially — and can feel more

connected to their colleges.

Fiscal conservatives would

object to the increased costs of

these changes, but converting fi-

nancial aid from loans to grants

would constitute a significant in-

vestment in America’s produc-

tivity and eliminate much of the

costs and bureaucracy associ-

ated with loan programs.

Bankers might also object

strongly to such a change be-

cause they would be losing a sig-

nificant revenue stream — the to-

tal student loan debt in the U.S.

tops $1.5 trillion. The average in-

dividual student loan debt is

more than $31,000 and takes 10 to

30 years to pay off. That’s a heavy

burden to take into the working

world.

The toughest education-fi-

nancing problem could well be at

the state level — especially

among state governments con-

trolled by Republicans that have

drastically reduced state finan-

cial aid support, which in turn is

forcing public colleges to regu-

larly increase tuition. In cases

where tuition increases are not

permitted, destructive cuts have

been made to student support

services, academic programs and

other vital offerings.

American higher education

has long been the envy of the

world, but polls show interna-

tional enrollment has been falling

for the last two years. It stands to

reason that the overt xenophobia

being exhibited by President

Trump is partly to blame as well

as the high cost of college tuition

in the U.S., where tuition and fees

at top-tier universities can add

up to about $60,000 a year.

How students manage to pay

the high costs of college has be-

come a major issue of concern

among Democratic presidential

candidates. “Free college for all”

may have a promising ring to it,

but given the complexities of stu-

dent financial aid it would be a

mistake to judge the efficacy of a

proposal for major change in col-

lege financing on the basis of a

simplistic label like “prog-

ressive.”

Alexander Astinis the

founding director of UCLA’s

Higher Education Research

Institute. His latest book is

“Are You Smart Enough? How

Colleges’ Obsession With

Smartness Shortchanges

Students.”

O

n the surface,the

notion of “free college

for all” sounds like a

good idea, especially

to progressives. What

supporters of tuition-free college

might not understand is that

transitioning from the current

U.S. system of financing higher

education to one where the stu-

dent pays nothing would thor-

oughly disrupt a workable system

that gives according to need and

charges according to ability to

pay.

The current approach has its

roots in the early 1970s, when

higher education officials — with

strong support from the Nixon,

Ford and Carter administrations,

and most state governments —

long ago subscribed to the notion

that every able student should be

able to afford college. This was ac-

complished through financial aid

that met each student’s needs

through a combination of grants,

loans and work-study programs

provided by the educational insti-

tution, private grants, and fed-

eral and state governments.

In the years since the big fed-

eral aid programs were put in

place, state and especially federal

financial aid has failed to keep

pace with ever-rising college

costs, causing the burden of pro-

viding sufficient aid to increas-

ingly fall on colleges.

The result is a sort of Catch-

for colleges, since the only way to

come up with more money for fi-

nancial aid is to raise tuition,

which of course increases student

need. State support for financial

aid also has been in sharp decline

since the Great Recession hit in

2008, exacerbating the dilemma

for public colleges. At the federal

level, the increasing demand for

more student aid also is being

met primarily by loans.

Today, students from rela-

tively affluent families often don’t

qualify for aid, most students

from middle-income families

must resort to loans to afford col-

lege, and poor students primarily

pay for college through financial

aid. For those looking for a social-

istic approach, that comes pretty

close.

In private colleges, much of

the financial aid for poor stu-

dents comes from tuition paid by

better-off families who must cov-

er the full price of their child’s ed-

ucation, and from the middle-

class families who might receive a

modest amount of aid and rely on

loans to make up the difference.

This also helps inflate college

costs because most colleges have

to increase tuition to cover the in-

creasing needs of poor students.

If we were to move from this

system to a “free college for all”

system, the wealthiest families

would receive a huge subsidy, and

the burden of paying for it all

would fall on all taxpayers, but es-

pecially the already-strapped

middle class. How socialist would

that be?

Some of the problem of financ-

ing college could be alleviated

merely by tinkering a bit with

what we already have.

The federal loan program is a

disaster, burdening middle class

and even some poor students

with massive debt. More than a

million people default on their

student loans each year. With

such a huge default rate, the loan

The fallacy of

‘free college for all’

By Alexander Astin

O

ne of manyfundamen-
tal facts of American
history it took me way
too long to learn was
this: For most of our
history, race riots, far from being
something angry black people did
in urban spaces, were something
angry white people instigated and
carried out against black people all
over the country.
Law enforcers were quick to
criminalize black populations in
big cities like Los Angeles and De-
troit for exploding in frustration in
the 1960s, but that kind of unrest
didn’t hold a candle to what whites
across the country did in the early
decades of the 20th century when
they felt black people needed to be
put in their place. The overtly crim-
inal behavior they employed, al-
ways violent and often deadly, in-
cluded stoning, shooting, lynching
and burning entire communities to
the ground.
The most infamous white riots
happened across the nation be-
tween April and November of 1919,
in what came to be known as “Red
Summer.” During that time, doz-
ens of racial skirmishes, stretching
from Arizona to Washington, D.C.,
left hundreds dead, injured and
displaced. Though the target of
most of the lethal violence was
black people, white rioters also di-
rected their economic and political
paranoia toward Germans, union-
ists and anyone sympathetic to
Russia’s Bolshevik Revolution. A
uniquely American fear that black
people would team up with Marx-
ists to bring about true economic
and racial equality intensified the
everyday racism that was already
at a boiling point — including in
Woodrow Wilson’s White House.
We are experiencing a version of
Red Summer now. Whites are not
rioting exactly, but individual white
men have gone on the rampage
in multi-ethnic, quintessentially
American cities like El Paso and
Dayton, Ohio. And their actions
feel an awful lot like white rioting by
another means.

The context is broader and

more diffuse these days, of course:

The El Paso shooter targeted Lat-

ino immigrants, while the motives

of the shooters in Dayton and

Gilroy, where another young white

man fired semiautomatic rounds

into a festival-going crowd on July

28, are much less clear at this point.

But the recent back-to-back shoot-

ings, taken together with so many

others in recent years, in Charles-

ton and Pittsburgh and Poway, to

name a few, are clearly rooted in

grievances nursed by a white male

populace losing its sense of place

and prominence.

They lash out with military-style

guns meant to blindly mow people

down, to kill as many as possible

without knowing or even having to

look at them — a lot like the indis-

criminate nature of racism itself.

Another link between Red Sum-

mer and 2019 is racism emanating

from the White House, aided and

abetted by layers of appointees and

elected officials unwilling to fully re-

pudiate racist and xenophobic sen-

timents. Of course, Trump has got

the patrician Wilson beat cold in

terms of the loathsome bigotry he

has spewed nearly nonstop since he

started running for president four

years ago. The difference between

then and now is that in 1919, racism

was the norm and white national-

ism uncontroversial; Wilson openly

admiring Klan ideology, for in-

stance, was unsettling for some, but

it was unsurprising. The president

and many other white Americans

sincerely believed that containing

the Other was noble and necessary

for keeping America great. If main-

taining segregation sometimes

morphed into domestic terrorism,

well, that’s just how it had to be.

In 2019 we are supposed to know

better — and want better. But a

good chunk of us do not. Some 40%

of voters still consistently support

Trump, and what that says about

our chronic inability to function as

a cohesive American people is a

truth we as a country are reluctant

to face. I’ve heard a lot of discussion

(again) about the shooters being

mentally ill or economically adrift

or internet-addled. We say such

things to assure ourselves that

these were individual acts, that

America is not fundamentally rac-

ist anymore, that these rampages,

hideous as they are, are about

something else.

But what? In all the heated dis-

cussions among liberals and con-

servatives about this latest spate of

violence, I have not heard anybody

articulate what that something

else might be. To say that hate has

no place in America, as hater-in-

chief Trump had the nerve to say

with a straight face before cameras

this week, is simply to lie.

Of course, there wasn’t even a

pretense of tolerance in 1919. For the

panicked white mobs bent on

maintaining the social order by any

means, tolerance was irrelevant,

even dangerous. This is also the

view of the growing club of white

shooters today who advertise the

fact that they feel threatened,

hemmed in and pushed out by

Mexicans, blacks, Jews, Muslims,

LGBTQ people, women and white

liberals who aren’t down with tribal

solidarity. Of course, most racially

fearful whites aren’t out there try-

ing to kill those who don’t look like

them. But a lot of white people do

embrace racial solidarity, even if

they won’t kill for it.

The fact that most racially un-

easy whites aren’t rampaging isn’t

cause for true optimism. But it’s

the shaky foundation on which we

have to build. And the 60% of us

who presumably reject Trump-era

racism and xenophobia can help

shore up that foundation dramati-

cally by not just saying we believe in

a unified America, but also by

putting that belief into action.

Erin Aubry Kaplanis a

contributing writer to Opinion.

IN 1919, the National Guard was deployed in Chicago during violent riots targeting black people.

Chicago History Museum

The ‘Red Summer’ of 1919

reverberates 100 years later

An aggrieved white

male populace

launched race riots

across the U.S.

By Erin Aubry Kaplan

Natural gas ban:An op-ed on

July 31 about Berkeley’s decision

to ban natural gas in new con-

struction stated that electric ap-

pliances don’t require venting.

Electric stovetops do require

venting.

FOR THE RECORD