Drug giant Pfizer’s record $2.3 billion fraud settlement with the government over its marketing of the pain medication Bextra should serve as a clue to everyone that all is not well with the pharmaceutical industry, which all too often puts profits above health.

For example, we are all inundated with those “ask-your-doctor-about” this or that drug TV commercials. You know, the ones that show a beautiful woman leaping through a field of flowers while the announcer drones on about potentially dangerous side effects.

It may surprise you to learn that only two countries in the world allow such direct advertising of prescription drugs to consumers, the United States and New Zealand. The rest of the world believes that whether you should get a prescription drug is something for a doctor to recommend to you, not something for you to recommend to your doctor.

Slick Advertising Gets the Go-Ahead

After passage of the FDA Modernization Act of 1997, however, drug companies were given greater freedom to advertise on television, as long as such ads are not misleading, and as long as the “major side effects” are mentioned during the ads. The idea is that consumers will become better informed about available drugs and will then bring the drugs to the attention of their doctors who may not have heard of the benefits such drugs can provide.

Yeah, right. A large drug company, like Pfizer, simply wants us to be better informed about the benefits of a Lipitor prescription so we can ask our ill-informed doctor about it. That’s why these companies sink millions into such advertising campaigns. (Given the incentives doctors receive from drug companies to prescribe their particular drugs, such encouragement is wholly unnecessary, but that’s a topic for another day!)

Big Drug Spends Big Bucks

Americans spend $200 billion a year on prescription drugs. Among the top selling and highly profitable prescription drugs being advertised on TV and their respective advertising budgets in 2005 were:

Nexium (acid reflux)- $224 million in advertising costs;
Lunesta (insomnia)- $214 million;
Vytorin (cholesterol-lowering)- $155 million;
Crestor (cholesterol-lowering)- $144 million;
Advair (asthma and COPD)- $137 million
Flonase (asthma and allergies)- $111 million;
Lamisil (anti-fungal)- $110 million;
Plavix (anti-clotting)- $110 million;
Cialis (erectile dysfunction)- $110 million;
Lipitor (cholesterol-lowering)- $93 million.

In its 2009 SEC filings, Pfizer (the largest U.S. drug company, soon to become even larger, after it merges later that year with Wyeth, another giant), states that among its biggest sellers are:

Lipitor ($12.4 billon in sales)
Celebrex ($2.5 billion)
Viagra ($1.9 billion)
Chantrix (almost $1 billion)

Yes, drugs are big business, and advertising helps.

Drug Pushers?

One of the biggest problems with this direct-to-consumer advertising is that it helps drive demand and costs upward by convincing more patients to “talk to their doctor,” thus presumably encouraging a doctor who is not currently prescribing the drug to start doing so. The real purpose of such advertising is not so much to inform the public as it is to drive choice, “typically in the direction of expensive brand-name drugs.”

Until all of this advertising started, who knew that high cholesterol was such a rampant medical condition in the U.S.? Who knew that so many middle-aged men were suffering from erectile dysfunction, and so many women suffering from active bladder syndrome? Now we have new drugs for “restless leg syndrome,” a condition many doctors believe is mostly over-diagnosed, driven by the media blitz (See: “How the Media Helps Make People Sick”).

All of these advertising costs help drive the cost of medicines sky high. Drug companies spend about 13% of their revenue on new research and development, seeking new drugs to help us all. Meanwhile, these same companies spend almost twice as much (25%) advertising their current product line.

The Rebranding Game

That may also explain why, of the 78 new drugs approved by the FDA in 2002, only 17 of them had new active ingredients, and only 7 of them were classified as “improvements over older drugs.” Most newly approved drugs are simply repackaged existing drugs, seeking to remain competitive in a crowded field and hoping to retain exclusivity and thus stem the tide of cheaper generic drug substitutes.

For example, when the “exclusivity” privilege held by the anti-depressant Prozac ran out (opening the door to any generic equivalent manufactured by anyone), Eli Lilly changed the color of the pill casing, renamed it Sarafem, and added PMDD (premenstrual dysphoric disorder, a rare condition) as a prescribed use. Result? The company was able to transfer the rights to its “new” drug to another company for $295 million.

Do Drug Ads Work?

Let’s take a look at a relatively new drug, Chantix. Chances are if you’ve been watching prime time television lately, you’ve noticed the new commercials for this “stop smoking” drug manufactured by Pfizer. Chantix was approved by the FDA on a fast track process in 2006. In the TV commercial, we watch a satisfied customer smiling at the camera while the background announcer is telling us that among the potential side effects are:

nausea
headaches
vomiting
seizures
abdominal pain
depression and suicidal thoughts
skin reactions
strange dreams

In 2008, the FAA banned the use of Chantix by airline pilots and air traffic controllers, based on concerns over psychiatric side effects. Despite all of this, sales of Chantix have already reached almost $1 billion.

Treat Us Like Patients, Not Consumers

Perhaps in a profit-driven industry, we can expect no less from private companies answerable to shareholders. It certainly pays off. Last year, Pfizer showed an $8 billion profit, and paid its CEO Jeffrey Kindler $13 million in compensation and benefits. The other major pharmaceutical companies also made healthy profits in an otherwise troubled economy (Abbot Labs – $3.3 billion; Merck – $3.3 billion; Wyeth – $4.6 billion; Eli Lilly – $3 billion).

But maybe all those other countries have a good idea in leaving the question of prescription drug needs in the hands of the doctors who know their patients best. And doctors, too, need to do their part in urging patients to change their life styles rather than just prescribing the latest cholesterol-lowering drug.

Drugs are not widgets. Whether particular prescription drugs are called for is a matter of both public interest and the private doctor/patient relationship. The issue should not be one for Madison Avenue.

Many of us take a vitamin or supplement (or several of them) every day hoping it will make us healthier. Unfortunately, when it comes to vitamins and supplements, there’s little regulation to determine if what you are taking is actually effective or safe.

It’s quite remarkable when you consider it’s a $30 billion dollar industry, but the Food and Drug Administration does not evaluate these products before they hit the shelves. Supplement manufacturers have few requirements placed upon them. The law prohibits them from selling products that are adulterated or mislabeled, and they cannot claim to cure things they don’t; but there is little oversight or enforcement.

The PBS program Frontline took an in depth look at the issue in its recent report Supplements and Safety. Click here to watch the program.

Frontline also shared this information to help you decide whether to take supplements:

Here are five questions a consumer may want to ask when considering supplements.

1. Has the product triggered any health warnings or sanctions?

Searching for a product or its maker on the FDA’s website will unearth any safety advisories or sanctions issued against them. The agency also maintains a list of all recent recalls and market withdrawals.

Because the supplement industry is constantly releasing new products, a product may be dangerous even if there are no advisories against it. A few minutes of online research may reveal key concerns about a supplement or its producer; the FDA has tips for searching the Web for information on supplements.

Researching individual ingredients can also be productive. For instance, Consumer Reports compiled a list of the “dirty dozen”: Twelve ingredients linked to serious adverse health effects, but that remain on shelves. The Federal Trade Commission also has a list of substances that have raised safety concerns.

2. Has the product been tested by independent labs?

Gaps in regulation have led to lapses in quality, even among mainstream brands. For instance, the New York Attorney General’s tests found that pills labeled as medicinal herbs sometimes contained little more than fillers like rice or houseplants. In some cases, supplements were filled with substances that could be harmful to those with allergies. Similar results were reached by researchers at the University of Guelph in Canada, who in 2013 DNA tested 44 herbal products from a dozen companies. They found that only two of the companies had products without any substitution, contamination or fillers in their products.

A handful of private, independent nonprofits have stepped in to partially fill gaps in regulation, inspecting some dietary supplements and reporting the results. The United States Pharmacopeial Convention (USP) runs a voluntary program to inspect and certify the quality of a company’s products and facilities. Those that pass can place the organization’s yellow and black “USP Verified” seal on their product — less than 1 percent of all supplements on the market have this label. The international public health nonprofit NSF International runs a similar program aimed at sports supplements.

Two other organizations, ConsumerLab.com and LabDoor, randomly test dietary supplements and report their findings. Both groups provide general review information for free; full results are accessible to paid members. ConsumerLab has also aggregated a long list of health warnings and recalls for more than a decade.

3. Is the product too good to be true?

Supplement producers are prohibited from making unfounded claims of health benefits — which is why many avoid declarations like “cures disease” in favor of softer assertions like “supports immunity.” Nonetheless, it is not uncommon to find pills that make overzealous claims. Such instances are red flags that a product may be fraudulent in other ways, according to the FDA.

So before taking a supplement, consider what is being offered. Is it being sold as a miracle cure? A magic pill? A wonder drug? The FDA says consumers should beware of products that claim to do it all, and to do so instantly. Experts warn that products that primarily offer evidence in the way of personal testimonials are worthy of skepticism, as are products that use suspect medical jargon, like these examples offered by the FTC: “molecule multiplicity,” “glucose metabolism,” “thermogenesis,” or “insulin receptor sites.” And just because something is labeled “natural” is no guarantee that it is safe to consume.

There are millions to be made through medical fraud, so consumers are asked to consider how they heard about a product. If the person recommending or prescribing it stands to gain financially, they may not have a consumer’s best interest at heart.

Many manufacturers offer money-back guarantees, no questions asked. But getting that money back may prove difficult or impossible. “Marketers of fraudulent products rarely stay in the same place for long,” writes the FDA’s division of emergency preparedness. “Because customers won’t be able to find them, the marketers can afford to be generous with their guarantees.”

4. Is there evidence that the supplement does what it promises?

Thousands of studies have been conducted on the effect of various substances on the human body. The National Institutes of Health has summarized what is known about the most commonly consumed supplements — vitamins and minerals — in a series of fact sheets. These explain how each vitamin or mineral behaves in the body, and the scientific evidence behind its health impacts. The U.S. National Library of Medicine’s MedlinePlus has similar information about other drugs, herbs and supplements. For a deeper dive into the science behind a specific supplement, explore the Library of Medicine’s PubMed Dietary Supplement Subset. The database includes scientific literature on vitamin, mineral, phytochemical, ergogenic, botanical, traditional Chinese medicine, and herbal supplements in humans and animal models.

Resources are also available for certain groups: The Department of Defense offers information about the safety of specific supplements to service members. Older adults can find resources aimed at them created by the FDA, the Federal Trade Commission, National Institute on Aging, and NSF International.

5. Do I really need supplements? If so, am I taking the right amount?

Health experts will say that your doctor is the best person to consult on whether vitamins or supplements are appropriate for you, and a pharmacist or registered dietitian may also have valuable input. People taking medications should exercise particular caution, since some supplements can interfere with their treatment.

As you research a supplement, think about dosage. Some otherwise safe vitamins and minerals can cause health problems if they are taken in excess. The Institute of Medicine’s Food and Nutrition Board produces recommended daily dietary allowances as well as tolerated upper intake levels.

Also worth considering is that a supplement may have considerably higher quantities of a vitamin or mineral than it says on the bottle. Because certain vitamins degrade over time, manufacturers often provide more than the labeled quantities, to ensure there is still the labeled amount at the expiration date.