ADHD and the Medication Feeding Frenzy in America

CORRECTION: In the post below, I make mention that there has been no U.S. media coverage on the MTA report. But after some further digging, I found coverage from Investor’s Business Daily, along with popular sources the New York Post, and Fox News and technical/niche publications like Planet Chiropractic. So there is some American coverage.

But if you click around you can see that the American stories are much more brief than their international counterparts. Each of the stories in the mainstream outlets is more of a newswire dispatch than an actual article, where as the international stories are comprehensive. And while pretty much all of the news sources of record in the U.K. covered the story, the major U.S. outlets–like the WSJ, NYT, Time, Newsweek, etc–seem to have had nothing.

Given that the U.S. is 90 percent of the ADHD drug market, you’d think that MTA’s findings would make nation-wide headlines. But instead coverage is scattered and superficial. Stories are relegated to quasi-interest group literature (investors who may lose money on the drugs, chiropractors who have a professional interest in questioning medication), or to the News Corporation (which owns both the Post and Fox news)–a multinational company with a strong Australian and British component. There’s still no convincing evidence that the American media is, on the whole, ready to meaningfully cover MTA’s findings.

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Earlier this week the British press broke some startling news: the Multimodal Treatment Study of Children with ADHD (MTA), has issued a report that claims there are no long-term benefits of ADHD medication for hyperactive children. Report co-author Professor William Pelham of the University of Buffalo, is quoted in the British press as concluding that ADHD medication is, in the long-term, all risk and no reward.

“The children [on ADHD medication] had a substantial decrease in their rate of growth so they weren’t growing as much as other kids both in terms of their height and in terms of their weight,” he says. “And…there were no beneficial effects – none.”

This is an about face from MTA’s benchmark report in 1999 that asserted with certainty that ADHD drugs were the best way to address ADHD in children. The 1999 study claimed that “combination treatments” (i.e. drugs and behavioral training) along with “medication-management alone” (i.e. drugs) are “both significantly superior” to other ADHD treatments that don’t include medication.

But, according to Pelham, “we exaggerated the beneficial impact of medication in the first study. We had thought that children medicated longer would have better outcomes. That didn’t happen to be the case.” So, according to Pelham, here’s the bottom line: “in the short run [medication] will help the child behave better, in the long run it won’t.”

To some, Pelham’s report might be unwelcome news. Thanks in part to the medical credibility that MTA and other studies have conferred on ADHD medications, global sales of ADHD drugs are predicted to be $4.3 billion by 2012. This ADHD boom is a recent phenomenon, largely a product of the 1990s. According to the US National Ambulatory Medical Care Survey, the number of children who received a diagnosis of ADHD increased 250 percent from 1990 to 1998. A study from 1996 showed that from 1990-1995 child use of ADHD medication increased by a factor of 2.5 and drug production increased six-fold. The production of Ritalin (the most common ADHD medication) increased by 700 percent from 1990-1999.

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Desperate, Drug Makers Court Doctors in Developing Countries

In the U.S. we are accustomed to seeing exceptionally well-dressed drug company reps strolling into doctors’ offices bearing trinkets: coffee cups, note pads and pens. We also know that they take doctors to expensive dinners, and host “continuing education” junkets to warm climes. Device-makers have been known to ferry doctors to strip clubs after dinner.

But in the developing world, drug makers are pulling out all of the stops. Often there is not even a pretense that the gift will help the doctor do his job. In Kashmiri, a physician confides, “representatives of pharmaceutical  companies offer cash, refrigerators, color televisions, laptops, PCs, mobile phones, ovens, phone bills, [and even to pay school] tuition [for your] children.”

In India, a doctor from Mumbai reports:  “On sale of 1,000 samples of the drug, you get a Motorola handset. On sale of 5,000 samples you get an air cooler. On sale of 10,000 samples get a motor bike.”

In Pakistan, a survey of 149 doctors, 100 medical information officers (sales representatives) and 99 medical store personnel, found that gifts may include included air conditioners, cars, cash, home appliances and domestic cattle.   Murad M. Khan, professor & chairman of the department of psychiatry at Aga Khan University, describes the latest practice: For writing 200 prescriptions of a company’s high-priced drug, a doctor is rewarded with the down payment on a brand new car.

These are just a few of the enticements documented in a November 2007 Consumers International (CI ) study, "Drugs, Doctors and Dinners: How Drug Companies Influence Health in the Developing World." (Thanks to Gary Schwitzer, at Schwitzer Health News Blog, for calling attention to this report.) A global voice for consumers, CI is an independent not-for-profit boasting over 220 member organizations in 115 countries.

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Human Growth Hormone and The Business of Immortality

Last week, James Forsythe, a prominent doctor in Reno, Nevada was acquitted by a federal jury after going to trial on allegations that he trafficked in human growth hormone (HGH). The decision came as a relief to the American Academy of Anti-Aging Medicine (A4M), because among other allegations, the doctor was accused of selling HGH as an anti-aging treatment, which is illegal in the U.S. A4M has a history of pushing for HGH-driven anti-aging treatments.

So what’s so special about HGH when it comes to aging? Beginning in your 40s, the pituitary gland slowly reduces the amount of hormone it produces, a fact that some feel is both responsible for the frailty of age and reversible through the introduction of synthetic growth hormones.

But there is little, if any, reliable scientific evidence about the anti-aging benefits of HGH. In fact, there are no double-blind placebo-controlled studies for most of the anti-aging miracle cures out there. Yet we do know for a fact that HGH can increase the risk of cancer—not to mention edema (retention of fluids), arthralgia (joint pain), carpal tunnel syndrome, diabetes, and gynecomastia (enlarged mammary glands in males).  Oh, and it might actually shorten life.

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When the Government Does What Drug-Makers Won’t Do

Today, Bloomberg News reported that “Deadly Staph Germs May Be Cured by Old, $1-a-Day Antibiotics.” It turns out that generic, World War II-era antibiotics are becoming “the newest weapon of choice in the fight against deadly, drug-resistant staph germs.”

Physicians have discovered that drugs costing less than $1 a day can be very effective when treating methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, recently made news by showing up in schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.  Annually, more than 18,000 Americans are killed by MRSA.

The physicians who mounted the studies of the older drugs were funded by the federal government. Meanwhile, in the for-profit private sector, Bloomberg observes, “drug-makers are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases.”

But physicians know the older, cheaper drugs work. “We have used these
older drugs with success for years,” says Gregory Moran, one of the
study leaders. He is a professor of emergency medicine at the Olive
View-UCLA Medical Center in Sylmar, California, affiliated with the
University of California at Los Angeles.

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Disease Mongering By Way of Restless Legs

Yesterday during lunch I saw an ad for Mirapex, a “prescription medicine used in
the treatment of moderate to severe primary restless legs syndrome (RLS).” The
fact that there was such thing as a restless leg syndrome seemed odd to me, so
I did some sleuthing. (Maggie, who has in fact discussed RLS over at the Health Care Blog, has some great
thoughts on the issue as well.)

 RLS is a “medical condition that is described as an urge to
move the legs”—simple enough. The Mirapex website offers a list of question
designed to help you diagnose yourself:

  • Do you feel a strong desire to move your legs from time to time, often when they make you uncomfortable?
  • Do those sensations in your legs occur or get stronger when you are inactive?
  • Does moving around or stretching help ease those uncomfortable sensations in your legs?
  • Do those uncomfortable sensations feel their worst at night?

Boehringer
Ingelheim Pharmaceuticals, the manufacturer of Mirapex, is considerate enough
to translate these symptoms into layman’s terms:

People often use words like
"burning," "creeping," "crawling,"
"aching," "tingling," and/or "tugging" to try and
describe their symptoms. Many people with restless legs syndrome have
difficulty explaining the odd sensations they feel, even when talking to their
doctor.

So far it seems that I may have RLS if my (1) legs get uncomfortable after
sitting for a while and (2) I have trouble articulating this sensation. By
these criteria, most anyone who has uttered the phrase “my leg feels weird”
qualifies as an RLS sufferer.

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We Can’t Fund SCHIP, But We Can Save Merck

Today, Bloomberg trumpeted the good news:  “Merck Profit Gains on Cancer Vaccine, Diabetes Pill.”

“Merck & Co., the third-largest U.S. drugmaker, reported a 63 percent gain in earnings,” Bloomberg reported, a victory made doubly by the fact that Merck has seen some rough times. “Competition from generics and the withdrawal of the pain pill Vioxx in 2004 over heart risks have pulled net income down 39 percent since 2001,” the story explained. Indeed, Vioxx gave Merck a black eye, and it’s still battling lawsuits in the courts. But Gardasil, Merck’s new vaccine to prevent cervical cancer, is turning out to be just the blockbuster the company needed. “Gardasil, introduced a year ago [already] has sales of $418 million”

Those of you familiar with my views on Gardasil may want to skip the below section, as it is pulled from an August post. I promise I won’t do this often, but this is an important subject and it’s example of how, if drug manufacturers and their lobbyists work quickly enough, they can sell their story to politicians and to the public before skeptics in the scientific community have a chance to weigh in. Remember the drug industry saying: “It’s important to sell a new drug while it’s still effective” (i.e. before people know too much about it).

On August 27, I wrote:

Earlier this month the FDA announced that the direct-to-consumer ads Merck has been using peddle its new cervical cancer vaccine, Gardasil, are “half-true . . .information currently being advertised could mislead the public.” 

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The FDA’s Moment of Truth by Niko Karvounis

Soon we’ll see what the FDA is made of.

Yesterday the AP reported that “doctors told the Food and Drug Administration advisers that the over-the-counter [cough and cold] medicines shouldn’t be given to children younger than 6 because they don’t help them and aren’t safe.” The final recommendation of an advisory panel of outside experts tasked with determining whether or not this is the case is due to the FDA late today.

By “not safe” petitioners don’t necessarily mean that the medicines themselves cause harm, but that they encourage reliance on “quick fixes,” an approach that can mask symptoms of more serious ailments.

This is obviously a problem in and of itself, but becomes an even a bigger deal when one considers that there are no known benefits to the medication. The drugs have never been tested on children—something the FDA has known since 1972. Instead, drug makers “have used extrapolated data from studies in adults to come up with dosing recommendations based on a child’s age or size.” Hardly rigorous medical science.

The threshold for unacceptable risk is a lot lower when a medicine does nothing. Michael Shannon from the Children’s Hospital Boston pediatrician and Harvard Medical School puts it best: “when a treatment is ineffective, its risks — if not zero — always will exceed its benefits.”

So what should worried parents do when their kids have a cold?

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If We Mandate Insurance, Should 20-Somethings Pay Less?

Should insurers be able to offer less expensive policies to the young and healthy? Or should they be required to offer the same benefits to everyone at the same price?

In states where insurance is mandated, should twenty-somethings get a break? In a post on Health Care Policy and Marketplace Blog Robert Laszewski addresses these questions. He begins by focusing on a report  just released by the health insurance trade association (AHIP). The study looks at state health insurance reforms of the 1990s that tried to eliminate discrimination by insisting that insurers must sell “individual” policies to people who are not covered by an employer or another group without discriminating on the basis of health, age or gender. According to the AHIP, these reforms have had some “unintended consequences.”

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Commenting on “The FDA Betrays its Mandate”

Commenting on "The FDA Betrays its Mandate,"  Gregory D. Pawelski  responded:
Take Physicians Out of the Retail Pharmacy Business
Lee Newcomer, with United Health Group, had stated at the 12th annual conference of the National Comprehensive Cancer Network, 44% of patients having blood work-ups indicated they were not anemic. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, reiterated that Newcomer was right on the spot on this. Few drugs work the way we think and few physicians/scientists take the time to think through what it is they are using them for.

A New York Times article stated that anemia drugs, given by injection, have been heavily advertised, and there is evidence that they have been overused, in part because oncologists can make money by using more of the drug. Lichtenfeld told United Press International, "Probably more than a billion dollars is spent on erythropoietin each year, which makes it one of the most expensive cancer drugs."

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Update–Gardasil for Boys?

A study published today in the journal Cancer suggests that cancers of the tongue and tonsils may be associated with the HPV virus that is linked to  cervical cancer. The theory is that  boys may contract the cancer through oral sex.  No surprise, the media is now asking: "Should boys be vaccinated with Garadasil too? (See my post below on Direct-to-Consumer advertising recommending Gardasil, a vaccine the against some cases of cervical cancer, for girls.)

The Wall Street Journal’s Health Blog takes a cautious approach pointing out, first, that "HPV’s connection to  to oral cancer isn’t as clear-cut as its role in cervical cancer," though  a New England Journal of Medicine article published earlier this year suggested a strong association. Moreover, while Merck and its rival GlaxoSmithKline (which is also developing a vaccine for cervical cancer) have done some  research on using their HPV vaccines in boys, they have even less data for boys than they have girls.  Finally,  "this form of cancer is rare.  . . .So for the time being, the vaccine, which costs $360 for a three-dose regimen, seems unlikely to be given to boys."

The Journal’s healthblog also notes that one of the study’s two authors "has worked as a consultant for GlaxoSmithKline."

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