pharmaceuticals

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Ritalin Nation: ADHD Drugs Not Studied Enough For Rare Or Late Risks

The ADHD drug Ritalin (Wikimedia Commons)

The ADHD drug Ritalin (Wikimedia Commons)

If we’re going to keep putting millions of American children on ADHD drugs, we really need to study the meds longer and better to pick up rare and late-onset side effects.

That’s my takeaway from a study just out from Boston Children’s Hospital. It found that in many cases, ADHD drugs had not been studied for long enough — really, can a clinical trial of a few weeks be long enough for a drug that’s typically taken for many years? — or in enough people. And drug company promises to keep studying the drugs’ effects even after the FDA approves them have often fallen by the wayside.

From the press release:

Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children’s Hospital report today in PLOS ONE. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

“This study doesn’t address whether ADHD drugs are safe, though their safety has since been established through years of clinical experience,” says study senior author Kenneth Mandl, MD, MPH, Boston Children’s chair in biomedical informatics and population health and director of the Intelligent Health Laboratory in Boston Children’s Informatics Program. “Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active FDA enforcement.”

The numbers: Continue reading

As Kids Grow, Oh, The Pills You’ll Take — And What They Cost

(Source: Health Care Cost Institute, Children's Health Spending Report, 2009-2012)

(Source: Health Care Cost Institute, Children’s Health Spending Report, 2009-2012)

When you become a parent, the word “development” stops referring to real estate and starts referring to the expectable changes that come as children grow. It’s “developmentally” typical for a child to walk at around 1, be talking some by 2 and be increasingly independent in the teen years.

Now, an informative new report just out from the independent Health Care Cost Institute, which mines millions of health insurance records, offers telling new data on what I would dub “pharamcodevelopment.” That is, as American children grow, what medications do they typically take, and at what cost?

One striking trend: Until teen girls start taking birth control pills, boys are significantly likelier to be prescribed drugs. (Yes, a lot of Attention Deficit Disorder meds, but not only.) Then, in the teen years, the genders tend to even out. The average total annual cost of children’s prescriptions ranges from about $169 per baby to about $500 per teen. I spoke with Carolina Herrera, director of research at the Health Care Cost Institute, for more insight. Our conversation, edited:

Is this report a “first” in any way?

These are the first numbers on children’s health care expenditures and utilization, and prices that were paid for their services, for 2012. The numbers are on 10.5 million children covered by employer-sponsored health insurance, weighted up to national averages covering every state in the union. So we have the first 2012 numbers on kids.

Between 2009 and 2012, what’s the most dramatic change or trend?

The most dramatic trend is probably that children’s health care spending grew at about 5.5 percent per year, and through the whole period, it grew faster than expenditures for most adult populations. Children’s health care spending per capita is a lower number than adults’, but we saw growth in quite a few areas. Prescription spending is definitely one of them. Spending on infants and teens is another. Both those groups had different motivating factors: For infants it was definitely hospital days; for teens, they continued using all the services they had used before and added more. In particular, we saw the prescription expenditures go up, and we saw the inpatient use for teenaged girls go up.

Inpatient mental health care for both teenaged boys and girls is definitely up. How much of that is coming from kids getting the care they need or families becoming more aware of possibilities of getting mental health care through the inpatient system? How much of that is occurring because maybe outpatient options weren’t available or appropriate? It’s really hard to tell at this macro level. That’s one of the areas we’ll be encouraging other researchers to look into more, and probably looking into more ourselves in our next big report.

Say you’ve just had a child. What does the data suggest you can expect for that child in terms of prescriptions over the next 18 years?

What’s interesting is what happens as the child ages. We start out life using gastrointestinal drugs and anti-infective drugs; those are the two most common drug classes we’re using. As the child gets a little older, to ages 4-8, there’s a shift. We see gastrointestinal drugs are no longer one of the top categories. We have anti-infective agents, though a smaller amount per child, and we see for the first time that the second-highest category of drug class use is Central Nervous System agents. CNS agents are typically associated with mental health care.

So that’s mainly ADD, Attention Deficit Disorder drugs? Continue reading

Mood-Altering Drugs We Pee Out May Affect Ecosystem

(Robbie Cada/Wikimedia Commons)

(Robbie Cada/Wikimedia Commons)

If the image of wild European Perch strung out on anti-anxiety meds doesn’t make you want to run out and become a hardcore environmental activist — right now — nothing will.

Indeed, according to this new report out of Sweden, pharmaceutical drugs that “end up in the world’s waterways after being excreted, flushed and treated at wastewater treatment plants may lead to unexpected ecological impacts over time.”

Those “unexpected impacts” include fish whose behavior can be transformed by these drugs: in this case the perch grew more gluttonous, risk-taking, bold, aggressive and antisocial, researchers report.

Here’s more from the news release; the study is just out today in the journal Science:

Many drugs leave our bodies unaffected, and residues from them are therefore found in wastewater. Low concentrations of drugs are often found downstream from sewage treatment plants. Today we test how dangerous drugs are to humans, but our knowledge of the environmental impacts of drugs is limited. For the first time, scientists have now been able to show how the behavior of fish is affected by involuntary medication.

Researchers have examined how perch behave when they are exposed to the anxiety-moderating drug Oxazepam. The changes were obvious in drug concentrations corresponding to those found in waters in densely populated areas in Sweden.

“Normally, perch are shy and hunt in schools. This is a known strategy for survival and growth. But those who swim in Oxazepam became considerably bolder,” explains ecologist Tomas Brodin, lead author of the article. Continue reading

May Cause Confusion: A Poem Composed From Pill Bottles

Peggy GIrshman's pill bottles (Courtesy of PG)

Peggy GIrshman’s pill bottles (Courtesy of PG)

Peggy Girshman is the executive editor of Kaiser Health News, a nonprofit news service that is a major new player in health journalism, widely valued for its reporting on health care policy and politics. These days, she’s also a patient, being treated for amyloidosis, which she describes below as “a rare, weird disease related to blood cancers.”

peggyportrait,jpg

Peggy Girshman (KHN)

Though she has covered health care for more than 25 years, Peggy says, she has never before been moved to poetry. But here, she shares a late-night inspiration: A poem composed entirely of instructions from her pill bottles.

May Cause Confusion

Follow the instructions very closely
Take before first food. Stay fully upright
Smoking should be avoided
Take this medication by mouth with or without food
Drink plenty of fluids, unless your doctor directs you otherwise
Do not split, crush or chew the medication. Doing so may destroy the drug
Take by mouth at least 1 hour before or 2 hours after a meal
If the tablet falls out before using, throw it away
Avoid exposure to sunlight
Take with full glass of water
Take with food or after a meal
Take on an empty stomach
Must agree to use 2 different forms of effective birth control at the same time
This product may contain inactive ingredients, which may cause allergies Continue reading

Update: Dr. Daniel Carlat On Gift Ban Repeal


Ah! Just as I’d been hoping, Dr. Daniel Carlat has weighed in on the House wine-and-dine vote to repeal the state’s ban on gifts to doctors by drug- and device-makers. Dr. Carlat, a local psychiatrist trained at Massachusetts General and author of the recent book “Unhinged,” has written about the corrupting influence of gifts to doctors better than anybody else I know. Along with reporting and analysis, he shares personal confessions that have long since expiated any past sins.

On the Carlat Psychiatry Blog here, he spoofs the repeal’s backers. A couple of my favorite excerpts:

Simply put, physicians need this food subsidy, because in Massachusetts, the median physician income is a paltry $216,700, according to the Massachusetts Medical Society. This is only 7 times the median Massachusetts income of $30,751. Those who say that doctors are “10 times richer” than other people are engaging in ridiculous hyperbole.

The fact is, your doctor is hungry and shouldn’t have to pay for his own meal after having gone through medical school and residency. You try getting paged at 3 AM and to put an NG tube through someone’s nostrils. These are punishing experiences and doctors deserve special compensation.

Continue reading

House Votes For Wining And Dining Of Docs — What’s Your Reaction?

One Twitter headline this morning: “More corruption for health care.”

The lead news from the Massachusetts House of Representatives today is last night’s vote to limit municipal unions’ bargaining rights on health insurance. But this should not get lost in the shuffle: As The Boston Globe and The Boston Herald report, the House also voted to repeal the state’s ban on gifts to doctors from drug- and device-makers.

The rationale: the ban hurts the economy. The upshot: Let the wining and dining begin anew!

Backlash has already begun, in advance of the Senate’s expected vote on the issue in coming weeks. Our local AARP took quickly to its Internet guns on the issue. In a blog post, it concludes:

“Bottom line: The cost of free lunches and other perks for prescribers should not be footed by consumers who are struggling to afford their medication. AARP will fight to keep the gift ban on the books, and to bring down the high cost of prescription drugs. We urge the Senate to do the right thing, and protect the prescription drug company gift ban.”

And today’s Globe story, by excellent newcomer Chelsea Conaboy, concludes:

Gift-giving gives pharmaceutical companies an upper hand, said Eric Campbell, research director at the Mongan Institute for Health Policy at Massachusetts General Hospital.

If repealing the law gives a little boost to restaurants and other businesses, he said, “does that become more important than ensuring the accuracy and the integrity and the quality of the information that health practitioners receive?’’

Readers, thoughts???

Report: Highest Paid CEO’s In Mass. Are In Health, Science

Health, science execs get the most generous pay in the state

Recession? What recession?

Not when you sit atop a company that sells health or science-related products, it seems.

According to the recent Boston Globe ranking of the highest paid CEO’s in the state, the top three spots belong to chief executives in the world of health care or science. Even more eye-popping than the CEO pay packages, perhaps, is the less-than-healthy state of their companies while they are in charge.

Here are the top dogs, then, in order of total compensation, according to The Globe:

Number 1: Marc N. Casper, Thermo Fisher Scientific Inc., a Waltham-based scientific instrument maker
Total compensation: $34.3 million

“…with 30,000 employees and annual revenues of $10 billion, announced in August that it will close its 60-employee plant in Rhode Island next June. The company also recently cut its yearly revenue forecast by $50 million, citing less favorable currency-exchange rates.”

Number 2: J. Raymond Elliott, Boston Scientific Corp., world’s second-largest maker of heart devices
Total compensation: $33.5 million

“Elliott earned a $1.5 million bonus in 2009, even though he joined the company halfway through the year and the company posted a $1 billion loss last year.”

3. Matthew Emmens, Vertex Pharmaceuticals Inc.
Total compensation: $19.3 million

“The company is seeking approval for telaprevir, a hepatitis C treatment drug, but currently has no drugs on the market and has lost money every year since it was founded in 1989, including $642 million last year.”