TagBig Pharma

The End of Prozac Nation and the Rise of Deep Brain Stimulation

Vaughan Bell on the shift from psychiatric drugs that act on one specific neurotransmitter in favor of a “circuit” driven model of treating mental and neurological disorders:

In its place is a science focused on understanding the brain as a series of networks, each of which supports a different aspect of our experience and behaviour. By this analysis, the brain is a bit like a city: you can’t make sense of the bigger picture without knowing how everything interacts. Relatively few residents of Belfast who live in the Shankill spend their money in the Falls Road and this tells us much more about the city – as these are the key loyalist and republican areas – than knowing that the average income of each area is much the same. Similarly, knowing that key brain areas interact differently when someone gets depressed tells us something important that a measure of average brain activity would miss. […]

Perhaps more surprising for some is the explosion in deep brain stimulation procedures, where electrodes are implanted in the brains of patients to alter electronically the activity in specific neural circuits. Medtronic, just one of the manufacturers of these devices, claims that its stimulators have been used in more than 100,000 patients. Most of these involve well-tested and validated treatments for Parkinson’s disease, but increasingly they are being trialled for a wider range of problems. Recent studies have examined direct brain stimulation for treating pain, epilepsy, eating disorders, addiction, controlling aggression, enhancing memory and for intervening in a range of other behavioural problems.

Full Story: The Guardian: Changing brains: why neuroscience is ending the Prozac era

See Also:

Deep brain stimulation to treat depression

The Curious Case of a Woman Addicted to Her Brain Implant

Adderal, A Love Story

Dose Nation‘s James Kent writes:

Adderall is a clever brand and a deceptive brand. In America, amphetamine has traditionally been associated with tweakers, speed freaks, bikers, truckers and all-night sex orgies. Adderall changed all that. Stimulants like Ritalin have long been shown to help people with ADD and ADHD (attention-deficit hyperactivity disorder) concentrate for longer periods. So in 1996, Shire Pharmaceuticals introduced Adderall, a patented blend of amphetamine salts, to compete in the market for ADD/ADHD medications. The product was so successful that in 2001, Shire introduced the Adderall XR capsule in order to supply a low but steady dose to users all day long. Adderall XR is marketed as a productivity drug to help people with ADD, ADHD or narcolepsy remain alert and focused, but because it’s essentially pure pharmaceutical amphetamine, it quickly became the prescription stimulant of choice for college students, wage laborers, the military, and pretty much everybody else.

Full Story: High Times: Adderall: America’s Favorite Amphetamine

(via Brainsturbator)

Previously: The Nazi Origins of Meth — AKA “Tank Chocolate”

What Happens When A Drug Works For Only One Person?

From Nature:

By all rights, Gerald Batist’s patient should have died nine years ago. Her pancreatic cancer failed to flinch in the face of the standard arsenal — surgery, radiation, chemotherapy — and Batist, an oncologist at McGill University in Montreal, Canada, estimated that she had one year to live. With treatment options dwindling, he enrolled her in a clinical trial of a hot new class of drugs called farnesyltransferase inhibitors. Animal tests had suggested that the drugs had the potential to defeat some of the deadliest cancers, and pharmaceutical firms were racing to be the first to bring such compounds to market.

But the drugs flopped in clinical trials. Companies abandoned the inhibitors — one of the biggest heartbreaks in cancer research over the past decade. For Batist’s patient, however, the drugs were anything but disappointing. Her tumours were resolved; now, a decade later, she remains cancer free. And Batist hopes that he may soon find out why.

The US National Cancer Institute (NCI) in Bethesda, Maryland, is recruiting stories, tissue samples and clinical data from up to 200 such ‘exceptional responders’ to learn why these patients benefited from drugs that failed most others. The effort is part of a larger push among cancer researchers to focus on single-subject, or ‘n-of-1’, studies that could offer new insights into the disease. The tactic initially met with resistance, says Charles Sawyers, a cancer researcher at the Memorial Sloan-Kettering Cancer Center in New York and an advocate of the approach. “It’s in vogue to talk about your n-of-1 study now,” he says. “But when I was in medical school this was called an anecdote — and it was a bad word.”

Full Story: Nature: Cancer researchers revisit ‘failed’ clinical trials

(via Boing Boing)

Drugs Giants Used Communist East Germany For ‘Illegal’ Trials

The Independent reports:

Leading Western pharmaceutical companies paid millions of pounds to former Communist East Germany to use more that 50,000 patients in state-run hospitals as unwitting guinea pigs for drug tests in which several people died, it was revealed today.

An investigation by the German magazine Der Spiegel said international conglomerates such as Bayer, Hoechst, Roche, Schering and Sandoz carried out more than 600 tests on patients, mostly without their knowledge, at hospitals and clinics in the former Communist state.

Full Story: The Independent: Drugs giants used Communist East Germany for ‘illegal’ trials

Flawed But Indispensable Take Down of Malcolm Gladwell

SHAME Project, an organization founded by Yasha Levine and Mark Ames of The Exile, recently published a lengthy critique of writer Malcolm Gladwell. I finally read it, and recommend it even though it is a flawed piece. Highlights:

While a student at the University of Toronto, Gladwell’s admiration for Ronald Reagan led him into conservative activist circles. In 1982, while still an undergrad, he completed a 12-week training course at the National Journalism Center, a corporate-funded program created to counter the media’s alleged “anti-business bias” by molding college kids into corporate-friendly journalist-operatives and helping them infiltrate top-tier news media organizations. To quote Philip Morris, a major supporter of the National Journalism Center, its mission was to “train budding journalists in free market political and economic principles.” Over the years the National Journalism Center has produced hundreds of pro-business news media moles, including top-tier conservative talent like Ann Coulter and former Wall Street Journal columnist and editorial board member John Fund.

After graduating from University of Toronto in 1984, Gladwell spent a few years bouncing around the far-right fringe of the corporate media spectrum. He wrote for the American Spectator—notorious in the 1990s as the primary media organ promoting anti-Clinton conspiracy theories—as well as the Moonie-owned Insight on the News. From 1985-6, Gladwell served as assistant editor at the Ethics and Public Policy Center, which was created to bridge the gap between neoconservatives and Christian fundamentalists and help the two hostile factions to come together to counter a common enemy: activists fighting for economic justice. Rick Santorum was a fellow at EPPC until June 2011, when he left to concentrate on his attempt to secure the 2012 GOP presidential nomination. […]

At the New Yorker, Malcolm Gladwell developed another branch of his branded Malcolm Gladwell, Inc. business: as a highly-paid corporate speaker. Indeed, Gladwell is ranked as one of the highest-paid speakers in America today, commanding anywhere from $40,000 to $80,000 for a single talk to corporations and industry groups eager to pay for his soothing wisdom. In 2007, Fast Company estimated Gladwell does “roughly 25 speaking gigs a year, his current going rate some $40,000 per appearance.”

That would translate into roughly $1 million that year in speaking fees alone—four times what he made at the New Yorker in 2005. It’s a huge amount of money, as far as speaker’s salaries go. For comparison: Mitt Romney only made $500,000 in speaking fees in 2010.

Most news organization have specific rules and guidelines about speaking fees, and some—including the Wall Street Journal, Bloomberg, and the Washington Post—ban their journalists from taking fees for speeches. But the issue is far from settled, and regularly comes up in debates about journalistic ethics. Jonathan Salant, former president of the Society of Professional Journalists Washington chapter, considers corporate speaking fees to be outright bribes. He’s not the only one.

In a March 2012 article in the Columbia Journalism Review, Paul Starobin wondered if speaking fees are a “dark and an indelible stain on journalism” and noted that most journalists would not talk openly about the details of their corporate speaker side-gigs on the record and that some tried to prevent their names from being mentioned at all.

Full Story: Naked Capitalism: Malcolm Gladwell Unmasked: A Look Into the Life & Work of America’s Most Successful Propagandist

(via Innovation Patterns)

There’s an excellent conversation on MetaFilter. Here’s an interesting point from Mr.Know-it-some:

I stopped reading after “the notorious National Bureau of Economic Research, an organization with ties to the tobacco industry and bankrolled by the biggest names in right-wing corporate propaganda funding.” NBER is probably the preeminent economic research organization in the United States, if not the world, whose (approximately 1000) members include left-wingers like Joe Stiglitz and Paul Krugman. (Yes, you might argue that it leans a bit corporate, but calling it “notorious,” is simply ludicrous.)

(Though someone else on the thread points out that Paul Krugman actually did briefly work for Enron).

The thread hits all the points I would want to make about what’s good and bad about the piece. It’s clearly an example of the “hit piece” genre, but it does make good points.

Maias wrote:

What’s equally infuriating is that sometimes his arguments— and those of pharma— are correct. The case of ADHD drugs is one instance: some people are genuinely helped and their stories get drowned out in the cries of “drugging our kids” and “overmedication.” The idea that crack dealers or tobacco companies are solely responsible for addiction is genuinely problematic— it ignores the fact that people with addiction *do* tend to have underlying issues and the fact that humans have always sought consciousness alteration. Making this case does not mean you are a pharma or a tobacco shill, merely that you have read the literature and know something about drugs.

Ironically, it is exactly the type of journalism exhibited by both this piece and by Gladwell that is the problem: ignoring complexity leads to simplistic solutions (let’s just lock up the dealers! let’s ban ADHD meds! let’s prohibit cigarettes! let’s ban painkillers!) that don’t actually work.

And mediareport wrote:

There’s more than enough direct evidence of Gladwell distorting evidence and hiding conflicts of interest – and then responding by not directly responding to the criticisms – to make the critique stick and stick hard. Linking it to Gladwell’s early conservative training is an interesting approach, too.

The stuff about the pharmaceutical industry and Gladwell’s laughably wrong attempt at a defense of Enron execs seemed excellent and very much on point. That the intent of the piece was to savage Gladwell’s moronic brand is clear, but that doesn’t invalidate the accumulated information, which accomplishes the goal nicely.

(However, a few people on MeFi made the claim that S.H.A.M.E. implied that Gladwell was a white supremacist – they did not. S.H.A.M.E. wrote: “Gladwell, who is part-Jamaican, apparently didn’t mind working for a white supremacist who argued that people like Gladwell were inferior” (emphasis mine). That said, yes, mentioning Gladwell’s own work debunking the the thesis would have been charitable.

See Also:

The Tipping Point and the Long Tail debunked

Why, Unfortunately, Malcolm Gladwell Matters

The Great Adderall Shortage

Kelly Bourdet writes for Vice Motherboard:

To prevent hoarding of materials and their potential for theft and illicit use, the Drug Enforcement Agency sets quotas for the chemical precursors to drugs like Adderall. The DEA projects the need for amphetamine salts, then produces and distributes the materials to pharmaceutical companies so that they can produce their drugs. But with the number of prescriptions for Adderall jumping 13 percent in the past year, pharmaceutical companies claim that the quotas are no longer sufficient for supplying Americans with their Adderall.

I hadn’t realized that it wasn’t known how these drugs work:

Despite the millions of prescriptions written each year for ADHD, the scientific community isn’t entirely in agreement on how these drugs actually work. Ritalin increases focus and energy through inhibiting the re-uptake of both dopamine and norepinephrine in the brain. These neurotransmitters then remain in the synapse longer, and their effects are felt in the form of heightened focus and awareness. Adderall, however, works via a slightly different mechanism. While it’s postulated that Adderall also inhibits the re-uptake of these same neurotransmitters, amphetamines also trigger the release of dopamine. This affects the brain’s reward mechanisms, so it’s not only easier to focus on mundane or repetitive tasks, it can also feel positively delightful to do so.

Motherboard: Anatomy of the Great Adderall Drought

The article also goes into some of the shadier aspects of the shortage – such as Shire’s missed shipments to competitors and the creation of its newer, more expensive alternative Vyvanse.

Why so much demand? From a recent Portland Tribune article:

Ritalin and Adderol are commonly prescribed for attention deficit disorder. But a recent study showed that as many as one in four students at an Ivy League university were using one of the two not because they had a diagnosis, but because it helped them study.

And it’s not just the students:

“I’ve had several colleagues say to me, ‘You’re a stupid guy if you’re not using Ritalin to stay up all night.’ You’re much more productive, your career takes off much faster,” says Paul Zak, director of the Center for Neuroeconomic Studies at Claremont Graduate University in California.

Zak isn’t sure that those Ivy League students and his college professor colleagues are doing anything wrong.

“I’m very conflicted,” he says.

And, on the subject Adderall, here’s an interesting paper: When we enhance cognition with Adderall, do we sacrifice creativity? A preliminary study. The study concluded that Adderall might actually improve creativity for those who score poorly on tests of creativity (for some background on creativity testing see here).

Why Are Anti-Psychotics the Most Common Prescription Drugs in America?

Has America become a nation of psychotics? You would certainly think so, based on the explosion in the use of antipsychotic medications. In 2008, with over $14 billion in sales, antipsychotics became the single top-selling therapeutic class of prescription drugs in the United States, surpassing drugs used to treat high cholesterol and acid reflux.

Once upon a time, antipsychotics were reserved for a relatively small number of patients with hard-core psychiatric diagnoses – primarily schizophrenia and bipolar disorder – to treat such symptoms as delusions, hallucinations, or formal thought disorder. Today, it seems, everyone is taking antipsychotics. Parents are told that their unruly kids are in fact bipolar, and in need of anti-psychotics, while old people with dementia are dosed, in large numbers, with drugs once reserved largely for schizophrenics. Americans with symptoms ranging from chronic depression to anxiety to insomnia are now being prescribed anti-psychotics at rates that seem to indicate a national mass psychosis. […]

What’s especially troubling about the over-prescription of the new antipsychotics is its prevalence among the very young and the very old – vulnerable groups who often do not make their own choices when it comes to what medications they take. Investigations into antipsychotic use suggests that their purpose, in these cases, may be to subdue and tranquilize rather than to treat any genuine psychosis.

Al Jazeera: Mass psychosis in the US

(via Mindhacks)

Life Without Serotonin

serotonin

I had no idea the link between serotonin and depression was in doubt. Very interesting:

Via Dormivigilia, I came across a fascinating paper about a man who suffered from a severe lack of monoamine neurotransmitters (dopamine, serotonin etc.) as a result of a genetic mutation. […]

Overall, though, the biggest finding here was a non-finding: this patient wasn’t depressed, despite having much reduced serotonin levels. This is further evidence that serotonin isn’t the “happy chemical” in any simple sense.

On the other hand, the similarities between his symptoms and some of the symptoms of depression suggest that serotonin is doing something in that disorder. This fits with existing evidence from tryptophan depletion studies showing that low serotonin doesn’t cause depression in most people, but does re-activate symptoms in people with a history of the disease. As I said, it’s complicated…

Neuroskeptic: Life Without Serotonin

See also:

Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature

The Black Hole in the Cost of Healthcare-pt 2: Computerized Healthcare

Imagine receiving a letter in your mailbox asking you to participate in a study for cancer research, and that your doctor didn’t mention anything about cancer during your last physical. This is what happened to 400 women in Maryland. According to the Baltimore Sun, ‘A state contractor tampered with Maryland’s cancer registry, a database used by researchers to track the disease’s impact, counting hundreds of patients as having cancer when they did not, according to a legislative audit released yesterday. The company, Macro International Inc., found in an internal investigation that data were deliberately altered between August 2004 and December of that year. The company fired the employee responsible for the cancer registry. State officials said that Macro employees apparently overreported the incidence of cancer to ensure that the database met standards set by a national certification association, which closely monitors registries to ensure that states have a complete count of cases.’ These letters were sent in 2005, and they’re just addressing it now.

If this can happen with a cancer registry’s database, imagine what could happen with someone’s personal health records. The argument for computerized records is simple. It will eliminate many errors that occur with paperwork, and will help emergency workers to assist a patient if the patient is unable to communicate. While this seems like a great idea in general, the issues of privacy, confidentiality, and abuses of the system lie in the back of many people’s minds. And for good reasons.

It’s not only our health records that are vulnerable. The WSJ Health Blog reports ‘In yet another example of the health industry mishandling private patient records, Blue Cross and Blue Shield of Georgia sent some 202,000 explanation of benefits letters to the wrong addresses last week, the Atlanta Journal-Constitution reports. The letters, which were mistakenly directed to the addresses of other policyholders, included names and insurance identification numbers of patients as well as the names of the doctors and other medical providers they were using.[..] A small proportion of the letters also had Social Security numbers, a spokeswoman for the company told the paper. Vulnerability to identity theft is one concern. But EOB letters are especially sensitive from a privacy standpoint because they contain some treatment information. And this is one of a steady stream of mistakes by the health-care industry when it comes to protecting electronic data. Blue Cross and Blue Shield of Georgia told the AJC that a computer system change was to blame, and it’s taken steps to avoid the problem in the future.’

I foresee many ‘computer system changes’ in the future. Is this what we have to look forward to? The steps they’re taking to ‘avoid the problem in the future’ currently may be completely different whatever steps are needed in the future. Will everyone be up to speed?

According to USA Today advocates for electronic prescribing ‘say it will have many benefits including decreasing medical errors, which harm least 1.5 million people every year, according to the Institute of Medicine. Doctors’ scrawl will be replaced with typed information, and potentially dangerous interactions with patients’ existing medications will be flagged.’ Yet privacy advocates are worried. ‘Transforming prescriptions from scrawl into a standardized electronic format can make them even easier for pharmacies to sell and trade, violating patient privacy, says Tim Sparapani, senior legislative counsel for the American Civil Liberties Union. ‘Any time you put something in a digital format and standardize it, it becomes much more profitable and easy to move those records.” The WSJ Health Blog also quotes the Coalition for Patient Privacy which said ‘While e-prescribing is attractive to many, Americans do not want their private prescription information data mined and used without their permission. Many Americans would be quite alarmed to discover their employer and others know they take an anti-anxiety medication or that they are being treated for an STD.’

I’m all for simplifying the paperwork process involved in healthcare. But I, like many others, am also worried about personal information being altered or available to those I don’t want accessing it. Will there be enough people enforcing our HIPAA rights? Will there be enough people to oversee these systems, to address immediate problems and to correct any glitches? Or will this be a windfall for Big Pharma and those who work in the field of law?

(Resources: Baltimore Sun-‘Md Cancer Statistics Altered’, WSJ Health Blog- ‘Insurer Sends Patient Info To The Wrong People’ and ‘Privacy Advocates Sound Alarm about Electronic Prescribing’, USA Today- ‘Writing is on The Wall for Doctors’ E-prescriptions’, Journal of Medical Internet Research-‘The Emergence of National Health Record Architectures in the United States and Australia: Models, Costs, and Questions’, and National Academy Press-” For the Record: Protecting Electronic Health Information” )

(See also: The Black Hole in The Cost of Healthcare: Big Pharma and Transparency)

FDA Whistleblower Site: Thoreau-FDA.com

“Welcome to Thoreau-FDA.com, a website launched and operated by current and former US Food and Drug Administration staff who believe public health is being put at unnecessary risk. These concerned civil servants and ex-civil servants have either experienced or are aware of wrongful directives by US FDA upper management – directives that put public health at avoidable risk. Thoreau-FDA stands for Thorough – High – Objectivity – Review – Ends – Are – Us – FDA. Here at Thoreau-FDA.com, you will find articles by its members that describe their efforts to protect all of us and our pets from harmful drugs and other medical products. And there are also reports of ordeals of other US FDCA staff, who are not involved in setting up this web site.

You can join others in discussion about the US FDA’s broken system by clicking on the link to FDA-blog.com. Or submit articles that will be considered for publication on our site by going to ‘Contact Us.’ Finally, we ask for your help. Read as much content on the site and related links as you need to convince yourself of the truth. Then, join an effort to effect real change at US FDA by sending a letter to the Commissioner of the US Food and Drug Administration. A sample letter is already prepared – but you can edit the letter to reflect your perspective. It prompts answers from the US FDA Commissioner about the effectiveness of the FDA’s ‘Values and Vision’ effort – a program that is supposed to correct many of US FDA’s problems that have persistently gotten worse over the last few years.”

(Thoreau-FDA.com. h/t: Pharma Law Blog)

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