Antibiotics and the Meat We Eat

ORIGINAL: NYTimes

By DAVID A. KESSLER 

March 27, 2013 

San Francisco 

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SCIENTISTS at the Food and Drug Administration systematically monitor the meat and poultry sold in supermarkets around the country for the presence of disease-causing bacteria that are resistant to antibiotics. These food products are bellwethers that tell us how bad the crisis of antibiotic resistance is getting. And they’re telling us it’s getting worse. 

But this is only part of the story. While the F.D.A. can see what kinds of antibiotic-resistant bacteria are coming out of livestock facilities, the agency doesn’t know enough about the antibiotics that are being fed to these animals. This is a major public health problem, because giving healthy livestock these drugs breeds superbugs that can infect people. We need to know more about the use of antibiotics in the production of our meat and poultry. The results could be a matter of life and death. 

In 2011, drugmakers sold nearly 30 million pounds of antibiotics for livestock — the largest amount yet recorded and about 80 percent of all reported antibiotic sales that year. The rest was for human health care. We don’t know much more except that, rather than healing sick animals, these drugs are often fed to animals at low levels to make them grow faster and to suppress diseases that arise because they live in dangerously close quarters on top of one another’s waste. 

It may sound counterintuitive, but feeding antibiotics to livestock at low levels may do the most harm. When he accepted the Nobel Prize in 1945 for his discovery of penicillin, Alexander Fleming warned that “there is the danger that the ignorant man may easily underdose himself and by exposing his microbes to nonlethal quantities of the drug make them resistant.” He probably could not have imagined that, one day, we would be doing this to billions of animals in factorylike facilities. 

The F.D.A. started testing retail meat and poultry for antibiotic-resistant bacteria in 1996, shortly before my term as commissioner ended. The agency’s most recent report on superbugs in our meat, released in February and covering retail purchases in 2011, was 82 pages long and broke down its results by four different kinds of meat and poultry products and dozens of species and strains of bacteria. 

It was not until 2008, however, that Congress required companies to tell the F.D.A. the quantity of antibiotics they sold for use in agriculture. The agency’s latest report, on 2011 sales and also released in February, was just four pages long — including the cover and two pages of boilerplate. There was no information on how these drugs were administered or to which animals and why. 

We have more than enough scientific evidence to justify curbing the rampant use of antibiotics for livestock, yet the food and drug industries are not only fighting proposed legislation to reduce these practices, they also oppose collecting the data. Unfortunately, the Senate Committee on Health, Education, Labor and Pensions, as well as the F.D.A., is aiding and abetting them. 

The Senate committee recently approved the Animal Drug User Fee Act, a bill that would authorize the F.D.A. to collect fees from veterinary-drug makers to finance the agency’s review of their products. Public health experts had urged the committee to require drug companies to provide more detailed antibiotic sales data to the agency. Yet the F.D.A. stood by silently as the committee declined to act, rejecting a modest proposal from Senators Kirsten E. Gillibrand of New York and Dianne Feinstein of California, both Democrats, that required the agency to report data it already collects but does not disclose. 

In the House, Representatives Henry A. Waxman of California and Louise M. Slaughter of New York, also Democrats, have introduced a more comprehensive measure. It would not only authorize the F.D.A. to collect more detailed data from drug companies, but would also require food producers to disclose how often they fed antibiotics to animals at low levels to make them grow faster and to offset poor conditions. 

This information would be particularly valuable to the F.D.A., which asked drug makers last April to voluntarily stop selling antibiotics for these purposes. The agency has said it would mandate such action if those practices persisted, but it has no data to determine whether the voluntary policy is working. The House bill would remedy this situation, though there are no Republican sponsors. 

Combating resistance requires monitoring both the prevalence of antibiotic-resistant bacteria in our food, as well as the use of antibiotics on livestock. In human medicine, hospitals increasingly track resistance rates and antibiotic prescription rates to understand how the use of these drugs affects resistance. We need to cover both sides of this equation in agriculture, too. 

I appreciate that not every lawmaker is as convinced as I am that feeding low-dose antibiotics to animals is a recipe for disaster. But most, if not all of them, recognize that we are facing an antibiotic resistance crisis, as evidenced by last year’s bipartisan passage of a measure aimed at fighting superbugs by stimulating the development of new antibiotics that treat serious infections. Why are lawmakers so reluctant to find out how 80 percent of our antibiotics are used? 

We cannot avoid tough questions because we’re afraid of the answers. Lawmakers must let the public know how the drugs they need to stay well are being used to produce cheaper meat. 

David A. Kessler was commissioner of the Food and Drug Administration from 1990 to 1997. 

Former Lab Rat Looks to Modernize Drug Software

ORIGINAL: Bloomberg

By Ashlee Vance

August 16, 2012

Courtesy Syapse

At the age of 7, while other kids were fiddling with Legos, Jonathan Hirsch found himself at a university lab learning the basics behind pipetting fluids and making gels. Five years later, Hirsch began conducting pharmacology experiments. It’s the sort of thing that can happen when much of your immediate family is made up of university researchers and doctors performing clinical trials. “I’ve just always loved doing research,” Hirsch, now 27, says.

As an undergraduate at the University of Chicago, Hirsch focused on biology and then later honed his neuroscience chops while getting a master’s degree from Stanford University. He also worked at Avocet Polymer Technologies and Abbott Laboratories (ABT)—a pair of pharmaceutical companies. Along each step of his journey, Hirsch grew frustrated by the antiquated technology tools at the disposal of researchers and doctors. They kept track of how a new drug was progressing through a trial using Excel spreadsheets and PowerPoint slides. When new results arrived, the researchers hopped back onto their computers to update information manually. “There was just such poor use of information,” Hirsch says.

In 2008, Hirsch decided to leave the laboratory and start a company to fix the issues he saw. He and a handful of young, like-minded scientists and engineers formed Syapse, a startup that would create a cloud computing service aimed at biotech and pharmaceutical companies and scientists and doctors. The goal was to provide these groups a contemporary way to manage data gathered through experiments and trials and to analyze that information.

“All of the people in our company are young scientists who grew up with Facebook (FB), Basecamp, and LinkedIn (LNKD),” Hirsch says. “We know what modern Web software can do to help us organize our lives. The data in this case is so complex and numerous and interrelated that you need a true platform to deal with it.”

At its core, Syapse has built a layer of software that helps organizations collect and categorize data from a wide variety of scientific instruments and to structure the data in a common way. It then sells different services tailored for specific tasks on top of that core product. Earlier this summer, Syapse began peddling one of the first additional services—called Discovery—aimed at collecting and analyzing genetic data. “A scientist can do research on a set of patients and specimens and set up a sequencing workflow that will keep track of the results,” Hirsch says. “He can then tie the results into studies on related gene sequences and generate reports based on the data.”

It’s early days for Syapse, to be sure, with the software used mostly in private trials so far. Dozens of universities have received access to the service for free as part of the company’s plan to train young scientists on the software before they go into the business world. Hirsch adds there are more than a handful of corporate users as well. The software starts at about $18,000 a year for a small startup and can go up to $500,000 a year for large companies with lots of people tapping into the service.

In his wildest dreams, Hirsch sees Syapse turning into something akin to the Windows of the drug world. He’d like the service to connect companies developing the drugs all the way through to the doctors dishing out the pills, creating an unbroken chain of data and analysis. “Today, doctors don’t have a tool yet that can show the history of a patient alongside their genomics information and drug options and the results from relevant studies,” Hirsch says. “So let’s bring together those pieces of data in a fashion that makes it possible to make a better decision.”

Syapse, with six employees, is in the process of seeking its Series A round of funding. It has already raised some money from angel investors, including its Chief Executive Officer Glenn Winokur, a software industry veteran. Hirsch, the company’s president, has largely paid his own way during the years spent developing the initial product. “I took all the money I earned from the earlier stuff and put it into Apple (AAPL) stock,” he says. “That’s how I support myself. I was fortunate.”

1. Vance is a technology writer for Bloomberg Businessweek.

Rationality's Rottweiler sinks his teeth in big pharma

ORIGINAL: New Scientist

 by Alison George

12 October 2012

"I think this is a cause for national scandal" (Image: Kris Krüg)

The scourge of bad science is at it again. This time Ben Goldacre has got the powerful pharmaceutical industry in his sights. And he's very angry

Of all the "bad science" topics you could have chosen, why decide to target the pharma industry in your new book, Bad Pharma?

I've been talking about bad behaviour by drug companies for many years now. The full story of how medical practice is distorted hasn't been told clearly enough. It's a huge interlocking ecosystem of failures that all work together to create a very dangerous system, and I think when the public learn about what's being done, they'll be angry.

What exactly is the problem?

Drugs are tested in poorly designed studies, which are then selectively reported, with unflattering data hidden. This biased evidence is then communicated to doctors in a chaotic and distorted system by marketing departments and Chinese whispers. I have an almost grudging respect for the clever ways in which data can be distorted, but as a result of this distortion patients suffer and die unnecessarily.

It's worth being clear that those in the industry aren't the only people at fault. Many senior academics, doctors, regulators and patients' associations have failed to protect patients' interests. I think this could be like the scandals of the expense claims of British members of parliament, or phone-hacking by journalists: things that feel normal within these communities may suddenly land some people in jail.

You call the situation a "murderous disaster". Isn't that a bit melodramatic?

Not at all. In medicine, evidence isn't an abstract academic thing, it's used to make real decisions. People die unnecessarily because of distortions in the evidence base. That's a disaster, that's murderous, and I can't think of any other way to express it.

If you've not read the book, you might think I'm some deranged conspiracy theorist... but if anyone's not going to be a deranged conspiracy theorist, it's probably me.

Are you hoping that the book will get people up in arms about this issue?

I think this is a cause for national scandal, but it's a sophisticated national scandal. It's not "oh my god, these people are deliberately killing babies". I don't imagine that any one of the people I describe in the book - who have made decisions that resulted in avoidable suffering or death - could willingly drown a kitten or suffocate an old lady. But when doctors give a treatment that they have been misled into believing is the most effective, they are inflicting avoidable suffering and harm on their patients.

But the pharma industry has produced many effective medicines, so it cannot be all bad, can it?

There is no medicine without medicines, and drugs companies have produced huge numbers of fantastic treatments. I'm totally fine that we have drugs companies innovating new products.

The problem is, if they are allowed to distort the evidence on how good a drug is, then they distort clinical decision-making in a way that harms people. These are systemic problems, affecting all of medicine.

What's the worst aspect of bad practice?

By far the most important issue is missing data. We know that about half of all trials that are conducted in medicine never get published, and that trials with positive results are about twice as likely to be published as trials with negative results. That's one of the reasons why, overall, industry-sponsored trials are about four times as likely to give a positive result, compared with independently funded trials. This results in a distorted picture. If a drug company can conduct many trials, but only publish the ones with positive results, then doctors are plainly misled about the benefits of that treatment.

What can be done to fix this problem?

We need clear regulations, muscularly enforced. Firstly, we need to make sure that every clinical trial has its results published within a year. Secondly, we need all the clinical trial results from past decades, which we now know are still being withheld, on drugs that are currently in use.

Are you hopeful that this will happen?

Every single intervention that people claim has fixed the problem of missing clinical trial data has, in reality, failed. Every single one. My hope for this book is that it will make it impossible for people to pretend that we have fixed this.

The pharma industry still claims, today, that it publishes all the evidence for all trials on all drugs, when the evidence shows that this is simply untrue. I would invite them to sign up to one simple commitment: "If we are ever found to be withholding any trial results on any drug, then we will pay back every penny we ever took from selling it." If they are so sure they publish everything, they should be happy to sign such a pledge.

How do you think Bad Pharma will be received?

I'm really interested to see how this book lands. It addresses some huge problems, a vast web of failures that all play off each other. If enough people learn about this stuff, that helps to move things on almost in itself. I'm sure it will be rubbished to high heaven and that there'll be elaborate smear campaigns to follow, but then I've had elaborate smear campaigns before from many industries and all kinds of disgruntled people. It goes with the territory.

Do you get hate mail?

I'm an investigative journalist. I've been on the receiving end of libel actions, crude attempts at blackmail, threats, and bizarre smears from journalists, quacks, anti-vaccination conspiracy theorists and major companies. Smears usually reflect pretty badly on the people making them - I'm never impressed when I see it done to other writers.

Did you ever imagine that a love of data and statistics would lead to you having such a high public profile?

I'm not famous, but I do recommend my own level of highly contextual microfame. Standing with the comedian Dara Ó Briain on London's Charing Cross Road at midnight would put you off proper fame for life. But anyone who recognises me in the street and says hello usually shares my interests, and has something interesting to share. It's pretty much ideal.

What's next for you?

There's lots of interesting stuff going on around evidence-based social policy, and I recently co-authored a UK Cabinet Office paper on randomised trials in government, with some very smart civil servants. It's a fascinating battle. For example, everybody thinks evidence-based medicine is a force of nature, but even 30 years ago many senior doctors regarded it as bizarre. "I'm the world expert, how dare you question me, I know what works from personal clinical experience." You see a lot of the same behaviour and beliefs in government and business, but that could change.

Then again, maybe after writing about the $600-billion drugs industry I'll be framed for some lurid and improbable crime, in which case: new horizons.

Profile

Ben Goldacre is a psychiatrist and epidemiologist specialising in "unpicking dodgy scientific claims". He wrote The Guardian newspaper's Bad Science column and a bestseller of the same name. His new book is Bad Pharma: How drug companies mislead doctors and harm patients (Fourth Estate)

From issue 2885 of New Scientist magazine, page 28-29.

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Es hora de actualizar su Software Biológico

ORIGINAL: ThinkBig

Versión en Español por Ciencia En Canoa

Daniel Honan

24 de marzo de 2012

Estamos en medio de la única mayor epidemia mundial de enfermedades crónicas en la historia de la especie humana. Se gastarán 47 billones de dólares en los próximos 20 años tratando con ella. El 90 por ciento de las personas que la tienen no son diagnosticadas, y sólo en Estados Unidos afecta a la mitad de la población. Esta enfermedad crónica es la "diabesidad", y se puede prevenir.

Así sostiene el Dr. Mark Hyman en un libro provocativo llamado La solución del azúcar en la sangre: El Programa de UltraHealthy para perder peso, prevenir enfermedades, y sientirse fantástico ahora! La solución es una palabra clave en el título, como Hyman establece 10 medidas claras y viables que permitan a la gente a "ocupar la atención de la salud" y tomar el control de su propia salud. Hyman llama este medicamento de enfoque funcional, enl oposición la medicina disfuncional. Le dijo a Big Think que la medicina funcional es "una nueva forma de pensar acerca de la solución del problema de las enfermedades crónicas." La Medicina funcional ve el cuerpo como "un sistema" más que "una colección de diferentes partes".

Hyman dice que este enfoque fundamentalmente impacta en nuestra comprensión de la salud o la enfermedad. ¿Qué importancia tiene este cambio en la medicina? Hyman dice Big Think:

"Estamos asistiendo a un cambio de paradigma que es igual al de Galileo diciendo que la Tierra no era el centro del Universo o de Colón diciendo que la tierra era redonda, no plana o Darwin diciendo que las especies evolucionaron en vez de ser entidades fijas."

En las próximas semanas estaremos presentando videos de entrevista reciente Hyman con Big Think. A modo de introducción, este mensaje se centrará en una de las cosas más básicas que Hyman dice que usted puede hacer para ser más saludable: comer comida de verdad.

Eso parece como un consejo bastante simple, pero hay un enorme sector de la economía de EE.UU. - una conspiración abierta, como Hyman la llama - que se configura para frustrar sus esfuerzos por ser saludable, porque es más rentable para esta industria si usted es obeso y poco saludable.

Hyman señala que mientras que la Fundación Robert Wood Johnson invierte $ 100 millones para combatir la obesidad infantil en este país, la industria alimentaria gasta que en cuatro días ese dinero para promover la comida chatarra y alimentos procesados. De hecho, mientras peor sea la comida para usted, más gasta la industria alimentaria en promocionarla.

Pueden gastar en ello y lo hacen. le dice Hyman a Big Think:

Hay una conspiración sin organización estricta para promover la enfermedad y la obesidad. Por defecto o por diseño, una tercera parte de nuestra economía se beneficia de personas que están enfermas y con sobrepeso, y se alimentan demasido, tanto que la comida industrial, la agricultura masiva, que es la agroindustria y las grandes empresas farmacéuticas todos se benefician de hacer que las personas estén más enfermas y más gordas.

Es por eso que Hyman dice que la mayoría de lo que se consume en Estados Unidos hoy en día no es realmente la comida. "Son preparaciones previstas para ser industrializadas" que dice Hyman "pueden parecerse a los alimentos, pero son Frankenfood en realidad."

Entonces, ¿por qué lo consumen? El marketing es una de las razones que ya hemos citado. Pero considere otra. Estudios científicos recientes ha demostrado que nuestra adicción a la comida es peor que la de los adictos a la cocaína y la heroína. De hecho, no es siquiera un tema de debate. "Cuando usted toma una rata y la pone en una jaula", Hyman señala que "si las ratas pueden tener cocaína o azúcar, van siempre por el azúcar".

En otras palabras, esta adicción es un fenómeno biológico. No se trata de fuerza de voluntad, y no debe ir a terapia para resolver el problema. Entonces, ¿cómo se puede ser un consumidor más sano? Commiendo alimentos verdaderos. Para decirlo de otra manera: ¿Le parecería a tu abuela que lo que comes es  alimento? ¿Comerá tu abuela un Lunchable o un Go-Gurt o "pink slime" (La base de residuos cárnicos que se usa para las hamburguesas? Por supuesto que no. ¿Por qué habría de hacerlo entonces tú?

En The Blood Sugar Solution, Hyman señala que los alimentos deben ser utilizados con fines medicinales. Usted puede reducir su adicción a la comida "al cambiar la información que va en su cuerpo y actualización de su software biológico." En otras palabras, "lo que se pone en la punta de su tenedor es más poderoso que cualquier cosa que usted encontrará en el fondo de una botella de un remedio."

Si quieres empezar este fin de semana, Hyman recomienda que usted debe poner comida de verdad en la cocina y pasar más tiempo en su cocina. "La mayoría de los estadounidenses pasan más tiempo viendo televisión que cocinando", dice. "La mayoría de los niños que crecen hoy en día en Estados Unidos no saber cocinar. Les estamos privando de sus derechos a las habilidades necesarias para crear su propia salud. ¿Cómo podemos crear una generación de ciudadanos conscientes y sanos alimentando a nuestros hijos con las cosas que sabemos que son venenosas y les van a matar? "

Imagen cortesía de Shutterstock