Selling Clinical Depression

Adding New Spin and Urgency to Depression Drug Sales
By MARTHA ROSENBERG

The discovery that many people with life problem or occasional bad moods would willingly dose themselves with antidepressants sailed the drug industry through the 2000s. A good chunk of the $4.5 billion a year direct-to-consumer advertising has been devoted to convincing people they don't have problems with their job, the economy and their family, they have depression. Especially because depression can't be diagnosed from a blood test.

Unfortunately, three things dried up the depression gravy train for the drug industry. Blockbusters went off patent and generics took off, antidepressants were linked with gory and unpredictable violence, especially in young users and -- they didn't even work, according to medical articles!

That's when the drug industry began debuting the concept of "treatment resistant depression." It wasn't that their drugs didn't work (or you didn't have depression in the first place), you had "treatment resistant depression." Your first expensive and dangerous drug needed to be coupled with more expensive and dangerous drugs because monotherapy, one drug alone, wasn't doing the trick!

You've got to admire the drug industry's audacity with this upsell strategy. Adding drugs to your treatment resistant depression triples its take, patients don't know which drug is working so they'll take all of them and the defective drugs are exonerated! (Because the problem is you.)

Now the drug industry has a new whisper campaign to keep the antidepressant boat afloat. Your depression is "progressive."

Once upon a time, when depression was neither seasonal, atypical, bipolar or treatment resistant, it was considered to be a self-limiting disease. In fact, just about the only good thing you could say about depression was it wouldn't last forever.

But now, the drug industry is giving depression the don't-wait scare treatment like coronary events (statins), asthma attacks ("controller" drugs) and thinning bones (Sally Field). If you don't hurry and take medication, your depression will get worse!

"Depressive episodes become more easily triggered over time," floats an article on the physician Web site Medscape (flanked by ads for the antidepressant Pristiq.) "As the number of major depressive episodes increase, the risk for subsequent episodes is predicted more from the number of prior episodes and less from the occurrence of a recent life stress." The article, unabashedly titled "Neurobiology of Depression: Major Depressive Disorder as a Progressive Illness," is written by Vladimir Maletic who happens to have served on Eli Lilly's Speaker's Bureau, says the disclosure information, and whose co-authors are each employees and/or Lilly shareholders.

On WebMD, a sister site to Medscape, the depression sell is even less subtle. An article called Recognizing the Symptoms of Depression, smothered with five ads for the Eli Lilly antidepressant, Cymbalta, submits, "Most of us know about the emotional symptoms of depression. But you may not know that depression can be associated with many physical symptoms, too."

Depression may masquerade as headaches, insomnia, fatigue, backache, dizziness, lightheadedness or appetite problems mongers the article. "You might feel queasy or nauseous. You might have diarrhea or become chronically constipated." And here, you thought it was something you ate!

The danger with these symptoms says the article is that you would fail to diagnose yourself as suffering from a psychiatric problem and buy an over-the-counter drug like a normal person. "Because these symptoms occur with many conditions, many depressed people never get help, because they don't know that their physical symptoms might be caused by depression. A lot of doctors miss the symptoms, too."

But when head and backaches aren't labeled as depression, the drug industry make no money and insurance rates could stop climbing from over-treatment with unnecessary, expensive and dangerous psychoactive drugs!

To prevent such goring of marketshare, the article (whose content was "selected and controlled by WebMD's editorial staff and is funded by Lilly USA," an original WebMD financial partner according to the Washington Post) counsels worry about physical symptoms. "Don't assume they'll go away on their own." Symptoms may "need additional treatment" and "some antidepressants, such as Cymbalta and Effexor, may help with chronic pain, too."

Before direct-to-consumer advertising, the health care system was devoted to preventing over-treatment and assuring patients they were probably okay. Who remembers "Take two aspirin and call me in the morning"? Now patients are assured they probably aren't okay but probably have a progressive disease. Luckily their disease can be treated with progressive prescriptions from pharma.

Vioxx All Over Again?

New Uses, Old Drugs
By MARTHA ROSENBERG

The withdrawal of Merck's "super aspirin," the COX-2 specific inhibitor Vioxx from the market may be as distant as the 2004 Bush-Kerry presidential election in the public's memory.

But it's not distant for Whitehouse Station, NJ-based Merck.

This week the drug giant's profits plummeted 90 percent from dedicating $950 million to resolve a government criminal investigation into Vioxx research and marketing, says the Philadelphia Inquirer.

Merck, accused by the New England Journal of Medicine of concealing "critical data on an array of adverse cardiovascular events" caused by Vioxx, already paid $4.85 billion in 2007 to settle thousands of Vioxx product-liability lawsuits.

Nor is it over for the 27,785 patients who suffered heart attacks and sudden cardiac deaths according to the Wall Street Journal.

Merck used Olympic gold medalist ice skater Dorothy Hamill to sell Vioxx -- I skate "five days a week for up to three hours," despite osteoarthritis she says in one ad -- and pushed it for everyday minor pain like menstrual cramps.

Merck sold Vioxx as safer and more effective than simpler aspirin and other over-the-counter pain relievers (and some suspect was behind warnings about the safety of Advil and Aleve, publicized soon after Vioxx hit the hot seat.)

Not that Merck was the only company selling COX-2 specific inhibitors.

Pfizer withdrew Bextra, a similar drug, in 2005 and last year agreed to pay $2.3 billion for fraudulent marketing of Bextra, Lyrica and two other drugs which was the largest criminal fine ever imposed in the US. Patients taking Bextra after heart surgery were 2.19 times more likely to suffer a stroke or heart attack said American Heart Association information.

Only five years earlier, Pfizer, a repeat offender, agreed to pay $430 million for abuses pertaining to seizure drug Neurontin and seven years before that, agreed to pay $49 million to settle charges it defrauded Medicaid by overcharging for cholesterol drug Lipitor.

Pfizer still manufacturers the COX-2 specific inhibitor Celebrex though it is also linked to life-threatening side effects included the case of Timothy Moorley, an outspoken patient in a class action suit against Pfizer in Canada, which is receiving wide publicity.

Though Vioxx and Bextra are gone and Celebrex is under a darkening cloud, the practice of prescribing unsafe drugs for simple pain that can just as easily be treated with older and over-the-counter drugs is alive and well.

FDA linked Lyrica and other seizure drugs to suicide in 2008 and mandated warnings, but Lyrica is widely prescribed off label in civilian and military contexts for pain and migraine -- no doubt from the marketing abuses Pfizer acknowledges in last year's settlement.

When Lyrica was first faced with a black box suicide warning, Pfizer sent FDA a 92-page appeal calling suicide statistics "an exaggeration of risk" that could "overwarn" patients and prescribers and make them "underestimate the risks of declining treatment." Especially revenue risks.

Lyrica, so similar to the deadly drug Neurontin it is called Son of Neurontin, is linked to memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and at least two deaths on the drug rating site askapatient.

Another dangerous drug now pushed for simple pain is Lilly's Cymbalta.

Many remember Cymbalta as the drug 19-year-old healthy clinical volunteer Traci Johnson killed herself on during trials on the Lilly campus in 2004 -- soon after FDA investigations into suicide/antidepressant links.

Johnson had no depression history said Rev. Joel Barnaby, a spokesman for the Johnson family, who called Lilly's decision to proceed with Cymbalta's launch as scheduled "offensive" posturing. Five others suicides occurred during Cymbalta clinical trials, said the FDA and twice the rate of suicide attempts were seen in women prescribed the drug for stress urinary incontinence -- also patients with no depression to blame.

Others remember Cymbalta as the drug Carol Anne Gotbaum, daughter-in-law of New York City Public Advocate Betsy Gotbaum, was taking during her macabre death in police custody at the Phoenix's Sky Harbor airport in 2007. There are 63 published news reports linking Cymbalta to depression, suicide and violence including the suicide of Ohio 15-year-old Megan Ficker three weeks ago.


This week, FDA approved Cymbalta for chronic musculoskeletal pain, "including discomfort from osteoarthritis and chronic lower back pain."

Cymbalta is the nation's fourth-most-advertised prescription drug and Lilly's second-best-selling product according to Indianapolis Star's John Russell, who has called it the Swiss Army knife of Lilly drugs. Last year it made a cool $3.1 billion.

Approved for depression, anxiety, fibromyalgia and diabetic nerve pain, the new osteoarthritis and chronic lower back pain indications should double Lilly's take. Already the front page of WebMD, the pharma mouthpiece web site whose original partner was Lilly, sports three Cymbalta ads -- one for depression and two for pain. Maybe Dorothy Hamill is available.