Congressman Bart Stupak (D-Mich.), chairman of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations, held a hearing today on the potentially misleading and deceptive tactics used in direct-to-consumer (DTC) advertisements for prescription pharmaceutical products.
The hearing, titled "Direct-to-Consumer Advertising: Marketing, Education, or Deception?" reviewed deceptive and misleading practices in three ad campaigns and explored better practices for DTC marketing. Stupak delivered the following statement:
Nearly 10 years ago, the U.S. Food and Drug Administration (FDA) relaxed its rules related to direct-to-consumer (DTC) advertisements for prescription pharmaceutical products.
Since then, spending on DTC ads has increased from about $1.1 billion in 1997 to about $4.2 billion in 2005.
This nearly 300 percent increase in DTC ad spending dwarfs the 86 percent spending increase in advertisements to physicians and the 103 percent spending increase in research and development over the same period.
The pharmaceutical industry insists that DTC ads are mainly an educational endeavor designed to educate consumers about new products.
Research shows that some DTC advertising result in patients seeing their doctor and discussing previously undiagnosed conditions.
We must acknowledge that DTC ads are also designed to market and sell these products.
Research has shown that DTC advertising may result in advertised drugs being prescribed when a similar, less-expensive drug may have been just as appropriate.
Every $1 spent on DTC advertising results in up to a $6 increase in sales, and one study demonstrated that every $1,000 spent in DTC advertisements resulted in 24 new prescriptions.
The purpose of the hearing is to examine the potentially misleading and deceptive tactics used in direct-to-consumer (DTC) advertisements (ads) for prescription pharmaceutical products.
Our hearing today will examine three specific television advertisements: ads for Lipitor featuring Mr. Robert Jarvik, 'Food and Family' ads for Vytorin and 'cancer fatigue' or 'quality of life' ads for Procrit.
Pfizer's Lipitor ads featured Mr. Robert Jarvik, an individual who has never held a license to practice medicine and has never been allowed to prescribe a medication.
For his participation in these ads, he was paid $1.35 million dollars; however, none of his ads indicates that he was compensated for his appearance.
In addition, Mr. Jarvik states, in one of these ads, that he himself takes Lipitor, yet he admitted in an interview that he didn't begin taking Lipitor until a few months after he began filming his commercials.
These ads are in violation of the American Medical Association's guidelines concerning the involvement of health professionals in DTC advertisements.
Mr. Jarvik's ads helped maintain Lipitor's position as the most prescribed anti-cholesterol 'stati' drug.
Merck and Schering-Plough's ads for Vytorin resulted in $5 billion dollars in sales in 2007.
However, while these ads peppered the airwaves, the release of an important study examining Vytorin's ability to stop cholesterol build-up was delayed and suppressed by the companies.
Significant, valuable results from this study were delayed for two years, while Vytorin was continuously marketed to consumers.
We now know that Vytorin has no effect on cholesterol build-up - however, this information came to us about two years too late.
Many consumers may not have taken Vytorin had they been aware of the study results, especially since a less expensive, equally effective generic drug, Zocor, was already available.
In addition, taxpayer dollars may have been needlessly spent on Vytorin through Medicare Part D as the drug was marketed to consumers while the company sat on its study results.
Johnson & Johnson's Procrit was approved by FDA to treat chemotherapy - and dialysis-induced anemia.
Yet for seven years, it was marketed directly to consumers for the treatment of 'cancer fatigue' in order to improve the 'quality of life' for patients.
This was clearly an instance of off-label marketing - a practice that is prohibited by FDA.
Not only did the company advertise the drug, but FDA did nothing to stop them.
These are three examples of drug companies acting improperly.
Our goal today is to expose the deceptive and misleading aspects of each of these television ad campaigns, but also those of DTC ads in general.
We also intend to explore better practices for DTC marketing.
Both the Lipitor ads with Mr. Jarvik and the Vytorin 'Food & Family' ads were voluntarily withdrawn shortly after our subcommittee began investigating DTC ads in January of this year.
However, American consumers should not have to rely on the oversight function of Congress to make sure drug companies tell the truth in their advertisement campaigns.
It is likely that DTC ads will continue, and pharmaceutical companies may continue using the same questionable practices that were used in these three ad campaigns.
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for regulating DTC ads.
Drug companies are required to submit copies of their ads at the same time that they are disseminated, but no preclearance is yet required.
If a DTC ad is found to be in violation of FDA regulations, FDA can issue written letters for serious violations, which may lead to regulatory action by FDA.
However, if a company refuses to comply, FDA cannot impose fines except through an administrative hearing.
Today we will hear from several witnesses, including the three pharmaceutical companies responsible for the Jarvik, 'Food & Family,' and 'cancer fatigue' campaigns.
We will also hear from the Kaiser Family Foundation about the effects of DTC ads, the American Medical Association regarding their policy on the portrayal of health professionals in DTC ads and the Government Accountability Office concerning FDA's role in regulating DTC ads.
We will also hear from Dr. Ruth Day from Duke University who will provide an overview of research on how people understand and remember information in drug ads and how to improve their ability to do so.
We will learn some of the techniques used in broadcast advertisements that affect how consumers process the information in DTC ads.
This information may reveal that it's not simply a matter of what is said in a DTC advertisement, but more importantly, what people take away from it.
The United States is only one of two countries that allows DTC ads.
Pharmaceutical companies should consider it a privilege to be allowed to air DTC ads in this country.
As with all privileges, there comes responsibility, and we should make sure that pharmaceutical companies conduct themselves responsibly.
The Food and Drug Administration shares the responsibility to make certain that drugs are marketed responsibly to consumers.
I also believe that Congress shares this responsibility, and I intend to make certain that our Committee ensures that pharmaceuticals market their products properly.
I believe that Congress needs to decide whether the U.S. should continue to be one of two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required.
If the three ads that we will discuss today are indicative of typical DTC ad campaigns, it appears that we need to enforce significant restrictions on DTC ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies.
I look forward to the testimony of each witness today, and it is my sincere hope that today's hearing will lead to a better understanding of the effects of DTC advertisements and their proper role in our health care system.
Comment: Tell your doctor if you experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems.
Side effects are generally mild or moderate and may include diarrhea, pain in the arms or legs, back, muscle, bone or joint pain, stomach pain or upset, or constipation. If you develop severe bone, joint, and/or muscle pain, contact your healthcare provider.
Women who are or could become pregnant should not handle this medication due to the potential risk of a specific birth defect. Do not donate blood until at least 6 months after stopping this medication. Tell your doctor if you have liver disease.
Tell your doctor if you have liver or kidney problems, as he doesn't know how to figure that out and you do.
Avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain and, in some cases, heart attack.
Some common side effects include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness, or faintness.
Contact lens wearers may produce fewer tears or have dry eyes.
Heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are administered in hot weather.
Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed."
"Important Product Information
. . . . . . . Since the product was first introduced, the following have been reported in patients:
* Serious Infections
* Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
* Some serious infections were fatal
* Rare cases of tuberculosis
* Do not start medication if you have an infection or are allergic to the medication or its components
* Tell your doctor if you are prone to infection
* Stop the medication if a serious infection occurs
* Tell your doctor if you have ever been treated for heart failure
* Rare reports of serious blood disorders (some fatal).
* Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness
* In medical studies of all TNF inhibitors, a higher rate of lymphoma (a type of cancer) was seen compared to the general population, however, the risk of lymphoma may be up to several-fold higher in RA and psoriasis patients.
You should not use this medication if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes or have severe kidney disease.
Tell your doctor:
* if you have had any infection in the past that keeps coming back, or if you have any problems that increase the risk of infections,
* if you feel any numbness or tingling,
* if you have ever had a disease that affects your nervous system such as multiple sclerosis, or
* if you have ever been treated for heart failure.
Tell your doctor right away or seek emergency care immediately if you have an allergic reaction such as a bad rash, swollen face, or trouble breathing. Tell your doctor right away if you have signs of a blood disorder such as persistent fever, bruising, bleeding or paleness.
You and your family should watch closely and call the doctor right away, if you have worsening depression, thoughts of suicide, or sudden or severe changes in mood or behavior (for example feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, hyperactive, overly excited, or not being able to sleep), especially at the beginning of treatment or after any change in dose.
Other side effects may include infection, diarrhea, dry mouth, constipation, decreased appetite, sleepiness, dizziness, sexual side effects, nervousness, tremor, yawning, sweating, weakness or insomnia.
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
* leg pain or swelling
* shortness of breath
* coughing up blood
* cough that doesn't go away
* blue-grey color or darkening around mouth or nails
* dizziness
* fainting
* blurred vision
* temporary confusion
* slow or difficult speech
* loss of memory or ability to concentrate
* hallucinating (seeing things or hearing voices that do not exist)
* extreme tiredness
* seizures
* weakness, numbness, heaviness, or tingling in arms or legs
* floppiness or loss of muscle tone
* lack of energy
* increased or rapid heart beat
* irregular heart beat
* chest pain or tightness
* excessive sweating
* fever, sore throat, chills, cough, and other signs of infection
* rash
* hives
* itching
* swelling of the face, throat, tongue, lips, eyes, hands, feet, or ankles
* wheezing
* difficulty breathing or swallowing
* hoarseness
Warning: Life-threatening if taken within 2 weeks of taking a MAO inhibitor.
In addition, the following side effects have been reported: anxiety, blurred vision, colitis, confusion, decreased levels of sodium in the blood, depression, fluid in the lungs, hair loss, hallucinations, increased levels of potassium in the blood, insomnia, low blood cell counts, menstrual disorder, palpitations, pancreatitis, ringing in the ears, severe increase in blood pressure, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo, worsening of epilepsy.
Call your doctor today for a free trial sample.
Comment: Tell your doctor if you experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems.
Side effects are generally mild or moderate and may include diarrhea, pain in the arms or legs, back, muscle, bone or joint pain, stomach pain or upset, or constipation. If you develop severe bone, joint, and/or muscle pain, contact your healthcare provider.
Women who are or could become pregnant should not handle this medication due to the potential risk of a specific birth defect. Do not donate blood until at least 6 months after stopping this medication. Tell your doctor if you have liver disease.
Tell your doctor if you have liver or kidney problems, as he doesn't know how to figure that out and you do.
Avoid stopping therapy abruptly. With certain beta-blocking agents, stopping therapy abruptly has led to chest pain and, in some cases, heart attack.
Some common side effects include shortness of breath, a slow heartbeat, weight gain, fatigue, hypotension, dizziness, or faintness.
Contact lens wearers may produce fewer tears or have dry eyes.
Heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are administered in hot weather.
Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed."
"Important Product Information
. . . . . . . Since the product was first introduced, the following have been reported in patients:
* Serious Infections
* Many occurred in people prone to infection, such as those with advanced or poorly controlled diabetes
* Some serious infections were fatal
* Rare cases of tuberculosis
* Do not start medication if you have an infection or are allergic to the medication or its components
* Tell your doctor if you are prone to infection
* Stop the medication if a serious infection occurs
* Tell your doctor if you have ever been treated for heart failure
* Rare reports of serious blood disorders (some fatal).
* Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness
* In medical studies of all TNF inhibitors, a higher rate of lymphoma (a type of cancer) was seen compared to the general population, however, the risk of lymphoma may be up to several-fold higher in RA and psoriasis patients.
You should not use this medication if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes or have severe kidney disease.
Tell your doctor:
* if you have had any infection in the past that keeps coming back, or if you have any problems that increase the risk of infections,
* if you feel any numbness or tingling,
* if you have ever had a disease that affects your nervous system such as multiple sclerosis, or
* if you have ever been treated for heart failure.
Tell your doctor right away or seek emergency care immediately if you have an allergic reaction such as a bad rash, swollen face, or trouble breathing. Tell your doctor right away if you have signs of a blood disorder such as persistent fever, bruising, bleeding or paleness.
You and your family should watch closely and call the doctor right away, if you have worsening depression, thoughts of suicide, or sudden or severe changes in mood or behavior (for example feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, hyperactive, overly excited, or not being able to sleep), especially at the beginning of treatment or after any change in dose.
Other side effects may include infection, diarrhea, dry mouth, constipation, decreased appetite, sleepiness, dizziness, sexual side effects, nervousness, tremor, yawning, sweating, weakness or insomnia.
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
* leg pain or swelling
* shortness of breath
* coughing up blood
* cough that doesn't go away
* blue-grey color or darkening around mouth or nails
* dizziness
* fainting
* blurred vision
* temporary confusion
* slow or difficult speech
* loss of memory or ability to concentrate
* hallucinating (seeing things or hearing voices that do not exist)
* extreme tiredness
* seizures
* weakness, numbness, heaviness, or tingling in arms or legs
* floppiness or loss of muscle tone
* lack of energy
* increased or rapid heart beat
* irregular heart beat
* chest pain or tightness
* excessive sweating
* fever, sore throat, chills, cough, and other signs of infection
* rash
* hives
* itching
* swelling of the face, throat, tongue, lips, eyes, hands, feet, or ankles
* wheezing
* difficulty breathing or swallowing
* hoarseness
Warning: Life-threatening if taken within 2 weeks of taking a MAO inhibitor.
In addition, the following side effects have been reported: anxiety, blurred vision, colitis, confusion, decreased levels of sodium in the blood, depression, fluid in the lungs, hair loss, hallucinations, increased levels of potassium in the blood, insomnia, low blood cell counts, menstrual disorder, palpitations, pancreatitis, ringing in the ears, severe increase in blood pressure, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo, worsening of epilepsy.
Call your doctor today for a free trial sample.