May kill you while not helping you....

Do Those Weird Pharmaceutical Ads Do More Harm Than Good?

by Martha Rosenberg

Do you wake up in the morning feeling groggy? Experience muscle fatigue after exercise? Perhaps you suffer from indigestion after eating spicy foods? Big Pharma has a potential cure for whatever ails you. It already sells 41 percent of the world’s drugs in the North American market, and one easy way to expand this market is to come up with new illnesses to treat.

“Anecdotally, I can tell you that if I got a dime for every time a patient asked for a drug by name, I would not need to go to work.”

Certainly diseases like ankylosing spondylitis exist. But many of the diseases marketed to consumers through direct advertising lack clear biological markers, and boil down to judgment calls. And Big Pharma’s “awareness ads” have created a nation of patients who don’t just “ask” their doctors if they have a disease they saw on TV — they often adamantly insist to their clinician that they’re suffering from a disorder. The ads work so well, some medical schools have had to teach doctors “refusal skills.”

It’s been 17 years since direct-to-consumer drug (DTC) advertising was permitted in the US — and the results were almost immediately apparent. As soon as people began seeing those “ask your doctor” ads, they started to suspect that they weren’t as healthy as they thought. Suddenly, they suffered from seasonal allergies, depression, erectile dysfunction, gastroesophageal reflux disease (GERD), irritable bowel syndrome, dry eye, restless legs syndrome, and worse. In fact, the parade of symptoms was so all encompassing, comedian Chris Rock said he was ready for an ad asking, “Do you fall asleep at night and wake up in the morning?”

DTC advertising, on which Big Pharma spends more than $3 billion a year, has done a lot more than sell pills. Through the industry’s “educational” efforts, it has sold new diseases to a worried public.

When people hear a radio or TV announcement about depression or ankylosing spondylitis, many think it’s an announcement from the Centers for Disease Control and Prevention or some other medical group concerned with public health. But most “disease awareness” messages are about Big Pharma trying to get people to diagnose themselves with a certain disease in order to churn “demand” for a new drug. The ads, also called “unbranded advertising,” are supposed to include the name of the pharmaceutical company paying for the message. But, because the FDA has thousands of ads to monitor, companies often omit the disclosure until they get caught.

And the punishment when they do? A letter from the FDA pointing out the error.

And now Pharma is selling diseases that require expensive and sometimes dangerous drugs. Many new drugs suppress the immune system. They may make the drug companies as much as $20,000 a year per patient, but while they can be useful for people suffering from autoimmune disorders, it’s unconscionable to market drugs with poor safety profiles to people who don’t really need them.

For example, patients treated with one popular immune suppressor, Humira, “are at increased risk for developing serious infections that may lead to hospitalization or death,” according to the drug’s warnings. These include “Invasive fungal infections, including histoplasmosis, coccidioidomycosi,” and “Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.”

In 2008, the FDA announced that 45 people died from such fungal diseases while taking Humira, Enbrel, Remicade and Cimzia. The same year, the FDA investigated Humira for 30 reports of childhood cancer and its links to lymphoma, leukemia and melanoma in children.

And in September, Xolair, a TNF-blocker marketed for asthma, was linked to a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, according to the FDA. Seventy-seven people who took Xolair, which carries a warning for severe allergic reactions, had life-threatening responses to the drug in just a year and a half, according to FDA reports. Scientific papers touting Xolair’s benefits were largely funded by its manufacturer, Novartis, and the FDA found irregularities when it investigated the facility where its original safety was tested in clinical trials.

In an attempt to widen the market for TNF-blockers, Big Pharma has marketed them for thinning bones (Prolia), chronic itch (Xolair), and assorted pain and gastrointestinal conditions, many of which can usually be treated with safer drugs. At this year’s American Academy of Allergy, Asthma, and Immunology annual meeting, Xolair was also presented as reducing symptoms of milk allergies.

Recently, AbbVie, which makes Humira, started “raising awareness” of ankylosing spondylitis, an inflammatory disease affecting the bones and joints, that happens to be treatable with Humira. A quiz to help people self-diagnose the condition asks “do you wake up with a stiff back” and “do you feel better after exercising”– two questions that would likely elicit a “yes” from anyone over 40.

“There is no relationship between public health needs and the direct-to-consumer (DTC) advertising” which makes “a disease popular,” wrote Madhusree Singh, MD in the Journal of the Society of General Internal Medicine. “Anecdotally, I can tell you that if I got a dime for every time a patient asked for a drug by name, I would not need to go to work.”

DTC drug advertising also takes up doctors’ already overbooked time, adds Singh. “When a patient requests a certain medication by name, I have to unpack the request and figure out what exactly he/she is thinking. Needless to say, this requires time that most primary care physicians do not have. I have noticed that even the World Health Organization sees this as a problem and that perhaps the tide is slowly turning.”

John Abramson, MD, author of Overdosed America: The Broken Promise of American Medicine and a clinical instructor at Harvard, agrees. DTC advertising “drives a wedge” between patients and physicians by playing on the patients’ “sense of autonomy,” he told CNN. “I could not convince many of my patients that the marketing they were hearing about Vioxx was maximizing the benefits and minimizing the risks,” he said about the popular painkiller that was withdrawn from the market a decade ago for doubling heart attacks in users. “That’s how powerful the advertising is.”

Many are amused or entertained by direct-to-consumer drug advertising but it is not innocuous. It stirs fear of obscure and unlikely conditions while ignoring real public health threats like heart disease, cancer and obesity. It creates hypochondriacs who want expensive medications for diseases they may not even have, and unnecesarily exposes them to dangerous side effects. And by selling the public expensive and optional drugs, its raises everyone’s health care costs.