14 Years of Pharma Direct-to-Consumer Advertising

Squeezing Docs, Hiking Insurance, Hooking Patients
By MARTHA ROSENBERG

Can anyone remember life before Ask Your Doctor ads on TV?

All you knew about prescription drugs were creepy ads in a JAMA at the doctor's office with a lot of fine print. Even if you knew the name of a drug, you'd never ask your doctor for it because that would be self-diagnosing and cheeky for a patient.

Flash forward to the late 1990s when direct-to-consumer (DTC) drug advertising, drug Web sites and online drug sales came on board, and self-diagnosing and demanding pills has become medicine-as-usual for the doctor/patient encounter.

The DTC/Web perfect storm didn't just sell drugs like Claritin, Prozac and the Purple Pill, it sold the diseases to go with them like seasonal allergies, GERD and depression. It sold risk of diseases like heart events for which you'd take a statin like Lipitor, osteoporosis for which you'd take a bone drug like Boniva and asthma attacks for which you'd use a second asthma drug like Advair. Of course, by the very definition of prevention, you didn't know if the drugs were working but you weren't paying out of pocket anyway so what the hay…

Thanks to DTC advertising, people started taking seizure drugs like Topamax and Lyrica for everyday pain or headaches and antipsychotics-- hello? -- for everyday blues or mood problems. They started taking monoclonal antibodies made from genetically engineered hamster cells like Humira that invite cancer, superinfections and TB when they didn't have to. And FDA mandated risk disclosures -- brain bleeds, sudden death, difficulty breathing, stomach bleeding, liver failure, kidney failure, muscle breakdown, fainting, hallucinations -- perversely increased drug sales either because people like the identity in having a disease, chemically experimenting on themselves and/or taking a dare or because ad frequency itself sells regardless of the message.

Soon anxiety graduated to depression which graduated to bipolar disorder. Children got schizophrenia and depression like adults and adults got ADHD like kids. And it didn't stop there. If the depression you or your kid had didn't go away -- maybe because it wasn't depression in the first place but a thing called "life" -- you needed to add a drug like Abilify or Seroquel on to the original drug(s) because your depression was "treatment resistant."

Of course if people were paying for the drugs out of their pocket and you told them to add a drug that costs almost $500 a month because the first one isn't working, they would say the only thing "treatment resistant" is your sales pitch -- go find another sucker. But if third party payers get stuck with the bill, no one seems to mind pharma's double-(and triple)-its-money plan -- or even notice it.

In fact psychiatric drug cocktails of eight, ten and twelve drugs are now common medical practice for "treatment resistant" depression and PTSD (often paid by government entitlement health plans) even though the drugs have never been tested when taken together. Unless you count the patients taking them now!

Pharma also adds an urgency pitch to the sell in case you think you can wait to take you or your child's treatment resistant drug cocktail until symptoms worsen. Depression is now a "progressive" disease say pharma-paid doctors after being known for decades as a self-limiting disease. (The one good thing you could say about depression; it would go away.)

And don't think kids will outgrow mood problems either, says pharma. That erratic behavior is no doubt early mental illness that will become Worse if you'd don't treat it in the bud. Even mothers of one-year-olds with the sniffles are told serious asthma is just around the corner if they don't treat their toddler now.

Pharma is also having a field day with sleep because everyone is in the demographic. In fact comedian Chris Rock riffs about hearing a DTC ad that asks, "Do you fall asleep at night and wake up in the morning?" and recognizing himself. "Yeah, I got THAT," he says."

Not falling asleep soon enough of course is the disease of insomnia which can have "strains" like "middle-of-the-night" and "terminal" insomnia. But it also sets you up for -- what's the pharma euphemism -- wakefulness problems the next day. And once you're using a wakefulness aid like Adderall or Nuvigil, what do you bet you'll have sleep problems?

Because of pharma-paid doctors, PR firms and industry subsidized medical journals and Web sites like WebMD, pharma is able to create new diseases (osteopenia, the "risk" of osteoporosis), perimenopause and Low T), "humanize" others by giving them nicknames (ED, RA, RLS, Hep C) and elevate others to public health problems like HPV/venereal warts. (It doesn't hurt that Julie Gerberding, MD, former CDC head resurfaced as head of Merck vaccines after she left the government.)

But a more insidious sell are pharma subsidized "patient groups" that lobby FDA and state agencies about expensive drugs, often psychiatric. While these "patients" -- often flown by pharma to testify at FDA hearings -- pretend they can't get needed drugs like terminal cancer patients, the issue is seldom availability but money: either they want a new use covered by insurers or don't want an older, cheaper drug substituted.

The same patients appear on Web site testimonials and phony grassroots PSAs (public service messages) about the epidemic of depression or childhood mental illness. How can you tell they're not real patients but pharma plants? The Web sites and PSAs look exactly like direct-to-consumer ads.

How Does the Drug Industry Get Away with Broadcasting Those Deceptive Ads?

The U.S. is one of only two countries in the world that allows Big Pharma to advertise directly to consumers. How did we get here?
By David Rosen, AlterNet
Posted on March 12, 2011

We’ve all seen them in newspapers and magazines, on TV and the Internet -- cheerful people in glossy, picturesque ads claiming that by taking a little magic prescription pill their lives were immeasurably improved.

As the TV ad fades, a cautionary voice quietly recites a host of “risk factors,” potentially catastrophic consequences that could result from taking the magical pill. One can’t but wonder if the cure is worse than the ailment.

A well-known ad features Dr. Robert Jarvik, a pioneer in the development of the artificial heart, pitching Pfizer’s cholesterol drug Lipitor. He comes across as a trusted expert with your best interest at heart, but viewers would not know that he is neither a cardiologist, nor licensed to practice medicine. (Lipitor’s 2009 sales were $5.4 billion.)

Another ad features Dorothy Hamill, the Olympic skating champion, skating effortlessly while promoting Merck's arthritis drug, Vioxx. The viewer would not know that Merck had for years knowingly withheld incriminating research from the Food and Drug Administration (FDA). The data would have barred the drug’s commercial release and may have saved the lives of an estimated 27,000 people who suffered heart attacks and sudden cardiac deaths after taking it. After Merck made billions, the drug was taken off the market.

These are two of a never-ending barrage of pharmaceutical advertisements known as direct-to-consumer (DTC) ads that bombard Americans day in and day out. Such ads are permitted only in the U.S. and New Zealand. They are intended to provoke an individual consumer to request a specific prescription drug from their doctor. In 2009, the pharmaceutical industry spent an estimated $4.5 billion on such advertising. Total 2007 U.S. pharma industry sales were $315 billion.

DTC ads give viewers the illusion that they can and should be their own doctor; they are designed to make viewers believe that they can and should prescribe for themselves. By fostering a false sense of demand for prescription-required drugs, DTC drug ads undermine the real knowledge that doctors should have when, in consultation with the patient, a treatment plan is established.

Next time you see one of these ads, make sure you are aware of the detailed risk factors that are either buried at the bottom of the page or mentioned at the commercial’s end. These risks tell only half the story of the drug’s real potential harm; the other half usually doesn’t get told: how the pharmaceutical industry is harming the health of Americans.

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Federal regulation of drugs was the result of public outrage over scandals exposed by early-20th-century muckrakers, most notably Upton Sinclair, who revealed widespread adulterated food products and poisonous patent medicines. This led to the passage of the Pure Food and Drug Act of 1906. In 1938, Congress passed the Food, Drug and Cosmetic Act that gave the FDA authority over drug company marketing materials. In 1962, FDA authority was further extended to regulate advertisements of prescription drugs.

However, things began to change in the 1980s. In 1981, Merck published the first DTC ad for a prescription drug, Pneumovax, in Reader’s Digest. It was followed by numerous print ads, and in 1983, the first television prescription drug ad for Boots Pharmaceutical’s Rufen, prescription strength ibuprofen.

Over the next decade-plus, the pharmaceutical industry, emboldened by the Reagan-era belief in “limited government,” steadily pushed to deregulate DTC ads. In 1997, the FDA loosened advertising rules leading to an enormous increase in DTC ad spending. For example, in 1996, less then $1 billion ($985 million) was spent on DTC ads out of the industry’s total promotional spending of $11.4 billion; in 2005, total pharma promotional spending nearly tripled to $29.9 billion and the amount spent on DTC ads quadrupled to $4.2 billion.

According to an invaluable 2007 study led by Dominick Frosch, “Creating Demand for Prescription Drugs,” a typical American television viewer can expect to spend 16 hours per year watching DTC drug commercials. This does not include the ads on radio, newspapers and magazines, billboards and the Internet. DTC ads typically focus on a handful of chronic conditions like depression, erectile dysfunction and insomnia.

Nevertheless, a perfect target for pharmaceutical intervention is America’s children and youth, and no condition has been more aggressively pursued than Attention Deficit/Hyperactivity Disorder (ADHD). Shire introduced Vyvanse in 2007 to replace its old blockbuster drug, Adderall XR, which had just lost its patent protection. The drug is targeted at children 6 to 12 years old, so the first DTC ads were placed in women’s magazines.

Some raised concern that the DTC ads violated the UN’s 1971 Convention on Psychotropic Substances, but the FDA brushed it off. The drug did include the following ominous warming: “MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.” Gone unstated in the DTC ads was the fact that Vyvanse is chemically based on methamphetamine, a Schedule II controlled substance like methadone, morphine and oxycodone. (Vyvanse’s 2009 sales were $660,000.)

Scheming pharma execs and ad agency hacks are not above inventing an illness to sell a new drug. A couple of years ago, Eli Lilly discovered a "new" female condition, Premenstrual Dysphoric Disorder (PMDD), to promote Sarafem, a form of Prozac. It was the first and only FDA-approved prescription drug to treat a woman’s menstrual cycle. Menstruation can be painful, and for some women even debilitating. Lilly exploited this, turning one of nature’s most primal bodily functions into a "disorder." The ad promised women that the drug would "help you feel more in control."

This new condition was a surprise to the American Psychiatric Association, which did not recognized PMDD as a disorder. It has proved so profitable because it turned a real, bodily experience (with, for many, pain and discomfort) into a disorder that can be cured. A magic capsule could now control an all-too-human condition that is as old as humanity itself, one that facilitates the species’ reproduction. Science had become witchcraft -- and with a hefty profit.

* * *

A DTC drug ad is designed to address two pharmaceutical industry concerns. First, it is intended to promote both new and established prescription drugs. Second, it is used to offset a drug’s competitive challenge from a generic drug.

Two questions determine a DTC drug ad’s effectiveness. First, does it work in terms of medical factors; i.e., does it help a person effectively address a medical condition? And, second, does it work as measured in corporate terms; i.e., does it get consumers to ask their doctors about the drug, get a prescription and get a sale?

While an answer to the first question remains unresolved, the answer is clear with regard to the second question. In 2010, Thomson Reuters polled some 3,000 Americans about drug advertising. The study’s principal findings were revealing:

• Nearly two-thirds of respondents say they've seen, heard or received some kind of advertising for a prescription drug in the last six months.
• One-third of respondents say they talked to their doctor about a drug and got a prescription for it.
• Three-fifths of respondents said their doctor was the principal source for information about the prescription drug

Not surprising, given the way people watch television, the study also found that many people didn’t pay much attention to the ads. Dr. Ray Fabius, chief medical officer for Thomson Reuters' health care and science business unit, noted "at least one-third of people aren't hearing them or tune them out."

Clearly, effectiveness of DTC ads is in the eyes of the beholder, whether measured against medical or business criteria. The pharma industry’s principal lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA), supports DTCs, since “getting that information to patients and consumers is the goal of direct-to-consumer (DTC) advertising about prescription medicines.”

And DTCs seem effective, particularly in generating new sales. According to a Kaiser study, Americans in 1992 got an average of seven prescriptions per year; however, in 2008, the average number of prescriptions nearly doubled to 12 prescriptions a year. Either people have gotten a lot sicker or DTC ads are doing their job. The report notes, DTCs have “added about $180 billion to our medical spending.”

Direct-to-consumer drug ads are ostensibly educational or informational messages designed to help Americans address critical medical issues. While the jury is out as to their medical efficacy, the ads' contribution to the bottom line is undeniable. The question that remains unanswered is how much DTC ads are harming the health of Americans.

Lawmakers Accuse General Motors of misleading the public

Perhaps you've seen this commercial:



video link

Turns out, many congressmen are saying it's bullshit.

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Lawmakers Accuse GM, Administration of Misleading Public Over Loan Repayment

A handful of lawmakers are accusing General Motors of misleading the public by continuing to claim as part of its advertising blitz that the auto giant has repaid its government loans "in full."

A handful of lawmakers are accusing General Motors of misleading the public by continuing to claim as part of its advertising blitz that the auto giant has repaid its government loans "in full."

General Motors has been running ads on all the major networks claiming the company repaid its $6.7 billion U.S. government loan "with interest five years ahead of the original schedule." General Motors Company CEO Ed Whitacre can be seen in the ad walking through an auto plant as he touts the company's progress.

But lawmakers, and even the inspector general for the bailout fund GM borrowed from, point out that General Motors only repaid the bailout money by dipping into a separate pot of bailout money. They say the company did not actually use its own earnings to make the early payment and are questioning why executives are making such a big deal out of it.

"The hype is not the reality," Sen. Charles Grassley, R-Iowa, wrote in a column on FoxNews.com over the weekend. "It is far from clear how GM and the Obama administration could honestly say, much less trumpet in prime time television ads, that GM repaid its TARP (Troubled Asset Relief Program) loans in any meaningful way."

Grassley wrote a letter last week to Treasury Secretary Timothy Geithner expressing his concerns and asking for more information about why the company was allowed to use bailout money to repay bailout money.

The $6.7 billion is also just a fraction of the $52 billion General Motors received in government aid. Grassley said lawmakers are being told government losses on GM are expected to exceed $30 billion.

The TARP inspector general, Neil Barofsky, bluntly told the Senate Finance Committee during a hearing last week that the repayment "is just other TARP money" and lawmakers should not "exaggerate" the feat.

"It sounds like they're kind of like taking money out of one pocket and putting it in the other to do that," Sen. Tom Carper, D-Del., said at the hearing.

Sen. Richard Shelby, R-Ala., expressed similar concerns Sunday on NBC's "Meet the Press," saying it's "misleading" for the administration to claim the company has paid back its loans.

The GM ad could potentially land the company in trouble with the Federal Trade Commission over its truth-in-advertising laws, which prohibit ads that are "likely to mislead consumers."

The FTC would not comment on the specific GM ad.

General Motors admits that the company is repaying the loan with other government money, but says a year ago "nobody thought we'd be able to pay this back."