|Viagra pills, made by Pfizer, |
pictured in this
undated file photo
Ever hear of Ankylosing Spondylitis?
If you are like most people, you have been watching "Ask Your Doctor" drug ads on TV for years. The ads, called direct-to-consumer drug advertising, have done two amazing things. They have made drugs like Claritin, Lipitor and the "Purple Pill" financial blockbusters—and they have, to a certain extent, "sold" the conditions behind them.
While the conditions these drugs treat—like seasonal allergies, GERD, high cholesterol, depression, bipolar disorder, adult ADHD, erectile dysfunction, Low T, irritable bowel syndrome, dry eye and insomnia—certainly exist, awareness of the conditions has greatly increased thanks to drug ads. In fact the parade of symptoms viewers may suffer is so over the top that comedian Chris Rock said he was ready to hear a TV ad asking, “Do you fall asleep at night and wake up in the morning? You may be suffering from….”
For many years, consumer drug advertising made Big Pharma Fortune 500's "most profitable industry. But now, the profit party is largely over, with blockbusters like Prozac, Lipitor, Viagra, Zyprexa, Symbicort and Nexium off patent and nothing much in the pipelines.
WebMD, one of the strongest online pill merchandisers, dismissed 250 employees a year and a half ago and medical journals are noticeably page light with fewer ads. Once booming companies are now seeking mergers commensurate with the Wall Street aphorism that in boom times companies spin off and in bust times they merge.
Four years ago Pfizer merged with Wyeth, Merck merged with Schering-Plough and Roche merged with Genentech. Now Novartis, GlaxoSmithKline and Eli Lilly are pursuing protective financial partnerships as the day of the drug blockbuster is over.
Still there are three diseases/conditions which Pharma is hoping may see it through the current lean times.
The successful diseases Pharma has marketed to sell drugs usually have snappy names or initials like ED, ADHD, RLS, GERD, IBS and Low T. That's why a new disease Pharma is pushing, ankylosing spondylitis, is gaining the nickname AS. Ankylosing spondylitis is an inflammatory disease that affects the bones and joints. But like depression, bipolar disorder, attention deficit and other lucrative diseases, the diagnosis of AS is a judgment call with no clearcut test. That's why Pharma offers a helpful quiz to convince people and hopefully their doctors that their back pain isn't from overexertion or a bad bed but AS.
If it is AS, back pain sufferers may just need Humira, a genetically modified, injected drug that costs $15,000 to $20,000 a year per patient. Drugs like Humira are "monoclonal antibodies" that suppress the body's immune system by blocking tumor necrosis factor (TNF). They are valuable for serious autoimmune diseases but increasingly marketed for less serious conditions.
For example, if you have back pain do you really want to take a drug whose label warns that "Patients treated with Humira are at increased risk for developing serious infections that may lead to hospitalization or death?" These include "Invasive fungal infections, including histoplasmosis, coccidioidomycosi," and "Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria?"
In 2008, 45 people died from opportunistic fungal diseases associated with such TNF blockers. The same year, the FDA investigated Humira for 30 reports of childhood cancers and its links to lymphoma, leukemia and melanoma in children. In 2011, the FDA also warned that Humira can cause, "a rare cancer of white blood cells," in young people. Five patients died during Humira trials in Italy that year.
Non-24 Hour Sleep Wake Disorder
“You can’t see me because of radio… and I can’t see you because I’m totally blind.” So begins a high saturation ad campaign that boosts “awareness” of an obscure circadian rhythm disorder called Non-24 Hour Sleep Wake Disorder-- launched by Big Pharma. How rare is Non-24? There are only 146 citations for the disorder in the entire U.S. National Library of Medicine. By comparison, there are 8,463 citations for the plague.
The narrator of the drug ads says blindness doesn’t “hold me back” but he often “struggles to keep up” because he is not “sleeping through the night.” He then says, “Sound familiar? You’re not alone!”--you might have this too! The ads are from the Washington, DC-based drug company Vanda whose drug, Hetlioz, recently received FDA approval for Non-24 Sleep Wake Disorder.
When I called the phone number for more information about Non-24 I asked my “health educator” if I could have the sleeping disorder even though I am not blind. I was told “you don’t have to be blind to have Non-24″ though it is more common in blind people. When I asked if there was a pill I could take, my educator said he was unable to answer that because, “I am not a doctor,” but promised to send me more information.
On the Non-24 website, we learn that the “The key symptoms of Non-24 are the inability to sleep or stay asleep and a powerful urge to sleep during the day.” Other symptoms include waking up “groggy,” being “less productive than usual at work or at school,” relationships that are "strained,” “sluggishness and forgetfulness,” mood that is “affected” and frustration “because no one seems to understand what you’re going through.” Clearly Non-24 Sleep Wake Disorder sounds like another disease Pharma has marketed--adult ADHD.
Is it really possible to convince people who didn't get enough sleep last night and need to drink a cup of coffee (and go to bed earlier) that they have Non-24? Yes, because advertising works.
Suicide Caused By Black Box Warnings
Imagine blaming U.S. obesity on a "deficiency" of the diet drugs Meridia and Fen-Phen which were withdrawn because of their dangers. Ever since SSRI antidepressants received black-box warnings for their suicide risk in young adults which cut into profits, Big Pharma has tried to blame rising suicide rates on a "deficiency" of SSRI antidepressants. (The reason they receive FDA black boxes is because they are known to cause suicide.)
The 180-degree chutzpah was spearheaded by Charles Nemeroff, who said in 2008, "The concerns about antidepressant use in children and adolescents have paradoxically resulted in a reduction in their use, and this has contributed to increased suicide rates." Such warnings "unnecessarily frighten families away from seeking treatment," he warned. Nemeroff was investigated by Congress for undeclared Pharma income and admits to at least nine Pharma financial links.
The warnings were a "barrier" to treatment, agreed David Shern, president of Mental Health America, in 2008, a group that was also investigated by Congress for its industry funding.
Even the New York Times carried the initial story about people dying from antidepressant deficiencies--until it was found to be inaccurate. While the statistics of rising suicides were correct, the drop in SSRI prescriptions that "caused" them had occurred the following year and the number of prescriptions in the cited year showed no change. Oops.
According to journalist Alison Bass, the paper on which the Times article was based was funded by a $30,000 Pfizer grant. An article[i] by the same author in the British Medical Jouranl, who had financial links to Wyeth and Pfizer, attributed veterans' suicides to SSRI deficiencies. What?
The fact is the Iraq and Afghanistan wars were a cash cow to Big Pharma with one in six troops on its drugs. A veritable pharma battlefield was created with troops marching on SSRIs, benzos like Xanax, anti-seizure drugs, anti-psychotics, pain pills and sleeping pills and receiving more of the same for PTSD. Prescriptions for Seroquel (an anti-psychotic which also has a black box warning) went up 700 percent and the SSRI antidepressant Paxil was the drug of choice during the Iraq war.
The military press itself reported on the overmedication and likelihood it was correlated with suicide. Military Times observed that the graphs of increased suicides in the military and increased drug prescriptions would fit exactly over each other. No wars before the Iraq and Afghanistan wars lost more troops to suicide than to combat--probably because the wars occurred before SSRIs.
It is often said that the presiding precept in medicine should be "first do no harm." The warning certainly applies to Pharma as it unethically tries to navigate its lean times.
[i] [i]. Robert Gibbons, Sharon-Lise T. Normand, Joel B. Greenhouse, Comment on "Risk of Suicidality in Clinical Trials Of Antidepressants in Adults: Analysis of Proprietary Data Submitted to US Food and Drug Administration," British Medical Journal 339, no. 7723.
Martha Rosenberg is an investigative health reporter and the author of "Born With a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health (Random House)."