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We Don’t Have To Give Up Our Place To Special Interests: Democracy Gives Us Options

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There is a practice in the Senate, primarily of corporate lobbyists, to hire low-income folks, usually minorities, to hold their place in line before Supreme Court or congressional hearings. There are firms that actually hire the standees, and contract with lobbying firms or corporations. Depending on the interest in the issue, standees can wait for hours before a hearing starts.  Last time I checked with one of them, a standee told me he earned $10 an hour.

Nonprofits don’t have those resources, so we get there early and hope for the best.  When we arrive, we face, usually in a line well in front of us, of weary looking people in jeans and tee shirts, holding up the signs of the individuals who will rush in with their $1,000 suits and shined shoes at the last minute and displace the standees.

Of all the abuses of corporate power in Washington, hiring line standers isn’t on the top of the list.  But its symbolism is inescapable.  The poor and disenfranchised literally give up their place to the wealthy and powerful.

I arrived 1.5 hours before the hearing on May 9 and there were nearly 10 line sitters ahead of me already. Photo: Flickr User SarahDeer

I arrived 1.5 hours before the hearing on May 9 and there were nearly 10 line sitters ahead of me already. Photo: Flickr User SarahDeer

Making compounded drugs safer

On May 9, the line standers were patiently waiting for the beginning of a Senate hearing on compounding pharmacies. It was too bad they wouldn’t be actually attending it. Like nearly all Americans, they will be affected by the decisions Congress makes about how these companies are regulated. Unlike a neighborhood pharmacy, where pharmacists prepare medications based on individual prescriptions for patients with special needs, compounding pharmacies now often serve hospitals or nursing homes and produce products in high volume, sometimes without individual prescriptions, and distribute their products across the country.

Late last year, a compounding pharmacy, New England Compounding Center, was responsible for an outbreak of bacterial meningitis that to date has killed more than 50 people and sickened more than 700. NECC was able to sell tainted injectable painkillers due to lax oversight by both Massachusetts regulators and the Food and Drug Administration.

The May 9 hearing addressed a legislative proposal to make compounding pharmacies safer. The decisions Congress makes on that proposal will affect anyone who ever gets surgery or an injectable painkiller. And yet the public, just like these line standers, generally doesn’t have a place at democracy’s table when these decisions are being made.

Bringing science into the debate

Neither, by and large, has science. Decisions about how best to regulate pharmacies that sell thousands of products to hospitals should be based on science. The evidence demonstrates that state boards of pharmacy lack the staff, and sometimes the authority, to do a good job policing these high-volume, high-risk operations. The FDA needs clear authority to regulate large compounding pharmacies to ensure the public health and safety.

We at the Union of Concerned Scientists are working with a coalition of public health, patient and consumer groups to strengthen the Senate proposal. The draft bipartisan bill would give the FDA power to oversee some, but not all, of these high-volume compounding manufacturers. The FDA wouldn’t regulate compounding pharmacies that made non-sterile products, even powerful high-risk medications, and it wouldn’t oversee compounding pharmacies that shipped all their products within one state.

The Food and Drug Administration (FDA) needs congressional approval in order to conduct better oversight of compounding manufacturers.Photo: FDA

The Food and Drug Administration (FDA) needs congressional approval in order to conduct better oversight of compounding manufacturers.Photo: FDA

Our coalition is pushing for FDA authority over all compounding pharmacies that make large volumes of products without specific individual prescriptions, regardless of the type of product or whether it is shipped in-state or across state lines. We also want Congress to give the FDA access to any pharmacy’s records, if the agency has received a complaint about the pharmacy, or has other evidence that suggests the pharmacy is breaking the law. Without the right to access records, the agency has to go to court to get that access, an exercise that can delay agency action, and place patients in jeopardy.

Pushing back against disinformation

And yet special interests, in this case pharmacy trade groups, appear to be doing all they can to weaken legislative proposals pending in the House and Senate.

Indeed, Senator Pat Roberts (KS) was so angered by what he termed a special-interest disinformation campaign that he refuted all the “myths” about the Senate’s proposal, inaccurate information that was stirring up fears among local Mom and Pop pharmacy operations who believed that they would be subject to intense FDA scrutiny.

But here’s the good news for both science and democracy. It doesn’t take a huge amount of engagement to make your views known to your Senator and have them count. This debate is being influenced by 2,000 emails from pharmacy interests. But 2,000 emails to the eight key Senators negotiating this proposal aren’t very many.

Compounding pharmacies like the one in New England responsible for the outbreak of fungal meningitis need stricter oversight. Photo: Flickr User Genista

If you are interested in the compounding issue, you can start to learn about it through the links in this blog, and an earlier blog, Compounding the Problem. You can let your Senator know that you are concerned about the safety of the drugs you may receive, and that you want Congress to pass strong legislation that ensures that all these high-volume pharmacies receive effective oversight and that the FDA has access to the records of any pharmacies that the agency suspects are breaking the law or harming the public without having to convince a court that the records are necessary.

People pick and choose what issues matter most. What is crucial is that in a democracy, we don’t give up our place. Our engagement can and does matter.

 

Posted in: Science and Democracy Tags: , , , , , , ,

About the author: Celia Wexler is a senior Washington representative for the Scientific Integrity Initiative at UCS. A former award-winning journalist, Wexler is the author of Out of the News: Former Journalists Discuss a Profession in Crisis, published in 2012 by McFarland. At UCS, Wexler’s issue portfolio includes food and drug safety, protections for scientist whistleblowers, and government transparency and accountability. See Celia's full bio.

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  • Donald Beams

    I just finished reading your graphic on The Healthy Farm and the Vision Policy Brief, and I wholeheartedly support that vision and the implementation of that vision via farmer activism and the modification of public policy, which would (should) accelerate the expediting of that vision. You clearly have the science backing the concept. You even have common sense, a crippled or abandoned tradition of stewardship and human decency backing the concept.

    And yet… You have all of those assets going for you on the topics of climate change and sustainable energy and it still is not enough to overcome ignorance and apathy (about 50% of the overall population) ignorance and hostility (about 47% of the voting population) and knowledgeable but thoroughly amoral greed-driven corporate interests (less than 0.5% of the population). The only other asset you have, politically speaking, is roughly 53% of the voting public, or maybe 25% of the total population. And just to the right of this box is an article by Celia Wexler with a tag line saying “Democracy Gives Us Options”… which would be fabulous if we actually lived in a Democracy…. but we don’t. Perhaps we never did.

    That is the current reality, and you do not need to be a scientist to figure that out. One needs only to take an eyes-wide-open look at the status of the nation. We are on a path to denigrating and degrading of education and a massive distrust of intelligence, logical thought and scientific knowledge. The disconnect from reality is epidemic in the nation, the stupidity and apathy and greed rampant and ascendent. The essential question to spend some time with is this: “How does a group of extremely intelligent, “concerned” and committed people alter the public conversation, quickly achieve a “critical mass” of not just interest but activism? Because having the facts, having common sense, having human decency on your side is not making the required difference?

    I have no intention whatsoever of putting anybody on the defensive with these remarks, although I have discovered from Facebook that one can engender extreme hostility, not to mention massive stupidity, with the most innocent and honest of observations. That is not what I am committed to.

    What I am saying is that there is something missing, an avenue or opportunities overlooked to have science make a difference in the political spectrum. Maybe it is in the arena of news media, a culturally significant event, movie or personality(s), a rich “Sugar Daddy for Science” or even a politician(s) to make a difference in this culture to interrupt the societal inertia and the political miasma. Is there a point of leverage not being exploited? Who really is the enemy of science = the enemy of the society? An impartial observer of our society would would quickly come to the conclusion that we ONLY mobilize when we are scared to death of a well-defined enemy. It isn’t scientific particularly, but it sure as hell is how societal shifts occur quickly enough to save us from an apocalyptic future.

    I tend to think that addressing that 0.5% will be more productive, more quickly than addressing the scientific knowledge, or lack thereof, of 75% of the population, but what do I know? I question the efficacy of a “Rednecks for Science” movement at this point in time. I just have questions, not answers. But I am almost certain that the answer lies in identifying, and dealing with the appropriate and pivotal questions. Because science, common sense and basic morality are clearly not enough by themselves to make a difference.

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