Health Supreme by Sepp Hasslberger

Networking For A Better Future - News and perspectives you may not find in the media

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November 29, 2004

Consumer Drug Advertising Challenged - Ads Emphasise Sickness Not Prevention

Are direct-to-consumer adverts for pharmaceutical drugs turning the US into a nation of hypochondriacs? Spyros Andreopoulos, who is director emeritus of the Office of Communication and Public Affairs at Stanford University Medical Center, certainly seems to think so.

Interestingly, the United States are, along with New Zealand, unique in the world for allowing such direct advertising and it appears that the U.S., with only 5 % of the world's population, is paying close to 50 % of all money spent on pharmaceutical drugs. Does all that spending result in better health? Berkely Prof Sydney Brenner, an expert on molecular biology, certainly is not convinced. He says people should be told to look after their health instead of expecting science to "come to their rescue with a pill".

National health statistics are difficult to compare as they do not all follow the same criteria, but on both infant mortality and on general healthy life expectancy, the US is nowhere near the top of the list as would be expected, if health care spending was equal to a healthy population.

Congress should deal with the question of direct-to-consumer advertising of drugs in the aftermath of the Vioxx withdrawal, says Spyros Andreopoulos in his opinion piece published in the San Francisco Gate, and he has several good reasons why...


A nation of hypochondriacs?

(see the original article here)

Spyros Andreopoulos

Monday, November 29, 2004

Merck's recall of its arthritis pain drug, Vioxx, because of elevated risks of heart attack and stroke has obscured another important issue that Congress, in investigating the matter, must face squarely and deal with: What happens when pharmaceutical companies pitch medicines directly to consumers. The company reportedly spent $100 million annually for marketing of the blockbuster drug.

The Food and Drug Administration opened this Pandora's box in 1997 when it relaxed regulations on how drug companies can advertise products directly to consumers. Advocates of this form of advertising argue that it provides valuable consumer education about medical conditions and treatments.

In reality it would not be too far-fetched to conclude that marketing by big pharmaceutical companies is transforming us into a nation of hypochondriacs.

It is now practically impossible to read a newspaper or magazine, listen to the radio or watch television without coming across an ad for a drug, or a disease you don't have but might get. The ads are clever -- as in the typical Viagra slogan of a middle-aged couple cuddling in bed under the caption "Bring back the spark that made you both happy."

The ads sometimes quote statistics of dubious accuracy. They generally focus on the prevalence of disease, but rarely on the effectiveness of the drug or risks, as is the case with ads published for doctors in medical journals.

More than 90 percent of the public reports seeing prescription-drug advertisements. The ads are designed to get attention by appealing to our deepest emotions -- the value of life and that of loved ones, the fear of disability, our vanity or getting old and decrepit. Alternatives and preventive strategies such as exercise or diet modification are rarely mentioned.

The ads routinely urge consumers to consult their doctors. But they also encourage them to ask for specific drugs. Doctors are trained as medical experts, but they are also trained to empathize with patients. When a patient demands a specific drug, doctors can experience significant conflict if they refuse to prescribe it. Some patients are known to change doctors if their requests are refused.

But doctors are not always innocent bystanders. They have allowed themselves to become fair game to the industry's sales soldiers. These are the "detail men" who visit doctors door-to-door, bringing free drug samples and a sales pitch about new products. Unfortunately, this marketing ploy has also become a primary source of information about new treatments for many busy doctors.

Another advertising gimmick is disease awareness campaigns. They involve informal alliances, composed of drug company staffs, doctors and consumer groups. Ostensibly engaged in raising public awareness about underdiagnosed and untreated problems, these alliances tend to promote a view of their particular disease as widespread, serious and treatable. Many "disease awareness" campaigns are often linked to companies' strategies to expand markets for new drugs.

Celebrity endorsements are also used, and mainstream media publish or broadcast "news" that is little more than free advertisements for drugs. TV news reports often show emotive images of a sick child or a disabled elderly person, impressive-looking medical equipment and often a medical specialist briefly interviewed to add professional credibility.

The fact that the new drug is often much more expensive or it is replacing an existing cheaper drug is never mentioned. Nor is there any reference that it will not be possible for several years to know whether it has any serious long-term side effects.

Many heavily advertised drugs are "lifestyle" drugs with marginal public- health benefits. Included are drugs for erectile dysfunction, baldness and anxiety disorders. Another category is the nonsteroidal anti-inflammatory drugs touted as having fewer side effects and being superior replacements for already established drugs.

Experts believe that direct-to-consumer advertising distorts the market by encouraging options more expensive and less cost-effective than existing options. Drugs meant for specific conditions are increasingly used in far broader populations beyond the scope of their original approval. Viagra and Cialis, for example, are heavily advertised to and increasingly used by a younger population, although the extent of the erectile-dysfunction problem is in dispute. Ads rarely mention, as studies have suggested, that erectile dysfunction may be caused by depression, excessive alcohol intake, smoking or prescribed drugs. And there is never mention of nonpharmacological treatments.

The U.S. drug industry has been very successful, with annual sales estimated at $250 billion. The industry has benefited from scientific and technological advances, new drug discoveries paid for by taxpayers, advances in therapeutic knowledge and changes in government and regulatory controls. However, increasing competition, patent expirations and the impact of managed care seem to have resulted in questionable marketing tactics to extend and expand profits at the expense of safety. Drug companies deny they're doing anything wrong, and insist that putting information into the public sphere is a good thing. But what they call information others call marketing, and there is only a fine line between the two.

Most of the civilized world prohibits advertising of prescribed medicines directly to consumers. Along with New Zealand, the United States is an exception. It is also faced with an FDA that is understaffed and cannot enforce the rules. Some have called on Congress to consider setting up a separate watchdog authority composed of physicians, scientific organizations and the media to identify misleading ads and levy fines on irresponsible companies. Others believe the drug industry would benefit more by institutional advertising in which companies put their good name and commitment to product safety before the public to restore consumer confidence.

Some academic medical institutions in Boston and on the West Coast are taking action on their own. To prevent faculty doctors and patients from getting caught in the hype that fuels sales of new drugs, Stanford, for example, has placed restrictions on drug salesmen on its premises. The university has also explicitly prohibited its doctors from dispensing free drug samples to patients. It may not be a bad idea if the American Medical Association and local medical societies encouraged similar restrictions on their members.

Spyros Andreopoulos is director emeritus of the Office of Communication and Public Affairs at Stanford University Medical Center.

24 February 2005 - A comment by the ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) on the recent FDA panel decision to not recommend withdrawal of Vioxx, Bextra, and Celebrex...

"Half of the drugs prescribed today are being used in situations where we don't have a good handle on whether they're either safe or effective, and that's a big problem."

But the problem is not being addressed in a forthright manner - neither by the medical community nor the FDA. Last week, FDA's advisory panel failed to meet the challenge before them: they did not recommend measures to prevent future, preventable, drug-induced catastrophes. That leaves drug safety issues to be resolved by Congressional action - and the courts. It is no coincidence that friends of the pharmaceutical industry are attempting to control the damage by lobbying to deprive citizens of just compensation for drug-induced harm.

The Washington Post reports that Dr. Alistair Wood, the Chair, advised the panel just before voting began that they were faced with "the biggest and most complicated drug safety issue to come before the FDA." He noted that "of the 16 drugs the FDA has taken off the market, none had affected nearly as many people because they involved relatively rare side effects and not a general cardiovascular threat."

The panel voted unanimously that all three COX-2 painkillers - Vioxx, Bextra, and Celebrex - "significantly increase" heart attacks and strokes, and agreed that the evidence for both safety and benefits was insufficiently documented. Despite agreement about the hazards, the panel was split on whether to allow these drugs to remain on the market.

The experts were unable to agree that a demonstrable increased risk of death outweighed any (admiteddly unproven) benefit greater than that provided by existing safer drugs. One wonders under what kind of cost / benefit analysis this decision would appear reasonable?

The rationale given by those who voted to allow drugs that induce fatalities to be marketed, is that the data from randomized controlled clinical trials is insufficient. But that rationale is contradicted by federal law which puts the burden of proof on drug manufacturers.

Federal law requires manufacturers to provide adequate scientific evidence of a drug's safety and effectiveness BEFORE obtaining an FDA license to market a new drug. But pharmaceutical companies are unwilling to conduct adequate controlled trials that are capable of detecting rare but lethal drug effects - they are not anxious to produce evidence that would jeopardize FDA approval. The FDA has betrayed its public responsibility of protecting the public from unsafe drugs by accommodating drug manufacturers. FDA officials have turned the law that was enacted to protect the public from unsafe drugs on its head: FDA policy ASSUMES a new drug is safe, until proven with absolute certainty, that it is unsafe.

Instead of requiring drug companies to demonstrate their products' safety by designing their tests to detect whether rare, but serious adverse effects exist, FDA officials demand that independent scientists who detect lethal drug effects demonstrate - in controlled clinical trials - with 95% accuracy - that the drugs pose a safety hazard.

FDA officials and their advisory panels disregard the human casualties linked to the drugs, arguing that documented evidence from the real world is not valid. The panel's split vote sends a mixed message to the public and physicians. The panel's failure to use the opportunity of uncontested drug induced cardiovascular fatalities to make recommendations that address the large safety issues - to prevent future drug induced catastrophes - demonstrates a colossal lack of political courage.

Critics view the panel's indecisiveness as a confirmation that drug safety is not a priority. How can physicians sworn to "do no harm" justify prescribing drugs with lethal side effects for conditions that are not life-threatening?

What assurance does anyone have that patients will be fully informed that chronic use of COX2 painkillers - as for arthritis pain - will likely be a trade off between future years of life in return for relief of pain that might well be had by using much safer and cheaper Aleve or aspirin?

The most stunning demonstration that commercial considerations, rather than safey, influence the drug approval and safety assessment process, is the panel's recommendation giving Merck the green light to market Vioxx. The advisory panel appeared to be less convinced by the evidence than Merck. The Washington Post reports that when it withdew the drug, "the company said it believed Vioxx could remain on the market with restrictions, but it decided not to do so because there were alternatives with fewer safety concerns." But safety concerns were clearly not a priority of a panel that voted to give Pfizer and Merck equal commercial opportunities even in the knowledge that lives would likely be sacrificed.

The Chicago Tribune reports that the panel's recommendation to ban direct-to-consumer advertising of painkillers that kill "could be the first step toward limiting a lucrative privilege the government granted the drug industry eight years ago." Restoring restrictions on drug advertising - say, for the first 10 years during which safety issues have not been resolved - will substantially reduce the number of people harmed by hazardous drug effects.

An added benefit of advertising restrictions would be to free the major media from its dependence on drug advertising revenues. This unacknowledged conflict of interest has rendered many reporters and editors timid about reporting the scope of harm produced by hazardous drug effects.

Contact: Vera Hassner Sharav

See also related:

Big Bucks, Big Pharma pulls back the curtain on the multi-billion dollar pharmaceutical industry to expose the insidious ways that illness is used, manipulated, and often created, for profit. Focusing on the industry's marketing practices, the video shows how direct-to-consumer pharmaceutical advertising glamorizes prescription drugs, and works to reinforce drug promotion to doctors. Pharmaceutical Research is seen as essentially uncontrolled and heavily skewed. Ultimately, Big Bucks, Big Pharma challenges us to ask important questions about the consequences of relying on a for-profit industry for our health and well-being.

Drug advertising can pay big dividends
Targeting patients directly raises sales of Crestor by 54 percent
AstraZeneca Plc. spent more to market Crestor to consumers than other drug makers spent on advertising for their cholesterol-reducing drugs, a move that helped boost Crestor's sales in the U.S. by 54 percent. The pharmaceutical giant, whose U.S. headquarters is in Fairfax, spent $166.5 million on TV, radio, print and billboard ads for Crestor during the first 11 months of 2006, according to an analysis by Nielsen Monitor-Plus, which tracks ad spending.

Tell Congress: Stop Prescription Drug Ads
Each year, drug executives spend $4 billion on prescription drug ads for pills they say will make you feel happier, sleep better and improve your sex life. The ads are not educational, and do not promote public health. They can be extremely dangerous, as the Vioxx tragedy shows. The Public Health Protection Act will stop all direct-to-consumer drug ads. Thirty-nine organizations have endorsed this legislation. Tell your Members of Congress to introduce the Public Health Protection Act. Take action now.

Prominent cardiologist criticizes drug ads
Los Angeles Times - Wednesday, December 29, 2004
The government should reassess its policy of allowing prescription drugs to be advertised directly to consumers, a prominent cardiologist urged Tuesday in the Journal of the American Medical Association.

Drugs aren't commodities to be hustled like cars and cookies

By ANDRÉ PICARD - The Globe and Mail
Thursday, February 24, 2005

One of the most important and overlooked recommendations of the U.S. advisory committee that held public hearings on the safety of Vioxx and other cox-2 inhibitors is a call to ban all advertising of the popular painkillers. It is clear to the panel members that advertising played a central role in this debacle.

Vioxx and Celebrex were among the most heavily advertised drugs in history. Their main claim to fame, touted in slick ads, was that they were safer than cheaper painkillers such as ibuprofen when, in reality, they increased the risk of heart attack and stroke. Advertising, in no small measure, led to the gross overprescription of these drugs to people with arthritis and other painful conditions. And it is telling that, when questions began to be raised about the safety of Vioxx, its maker, Merck & Co., responded by bolstering the ad campaign for the drug, not by commissioning research to investigate scientists' concerns.

Ads for drugs under fire
Bringing a drug to market is an expensive endeavour. Building a market for a drug can be pricey too. Pharmaceutical companies contend drug prices must be high to fund research and development. Yet these same companies typically spend twice as much on marketing and administration as they do on drug discovery.

British Medical Journal:
Only 6% of drug advertising material is supported by evidence

THE WASHINGTON POST - Doctors Influenced By Mention Of Drug Ads
Actors pretending to be patients with symptoms of stress and fatigue were five times as likely to walk out of doctors' offices with a prescription when they mentioned seeing an ad for the heavily promoted antidepressant Paxil, according an unusual study being published today. The study employed an elaborate ruse -- sending actors with fake symptoms into 152 doctors' offices to see whether they would get prescriptions. Most who did not report symptoms of depression were not given medications, but when they asked for Paxil, 55 percent were given prescriptions, and 50 percent received diagnoses of depression. The study adds fuel to the growing controversy over the estimated $4 billion a year the drug industry spends on such advertising. Many public health advocates have long complained about ads showing happy people whose lives were changed by a drug, and now voices in Congress, the Food and Drug Administration and even the pharmaceutical industry are asking whether things have gone too far.

"Big Pharma" Controls US "TV News"...
Opinion by Consumer Advocate Tim Bolen

Consumers Union - Thursday, July 21, 2005
Drug Industry's Voluntary DTC Plan is Placebo; Real Reform Needed to Ensure Accurate, Informative Drug Advertising

September 2005: UK: Crack Down On Drug Advertising
Pharmaceutical industry advertising is to be policed following concerns raised by MPs, the government says. But ministers stopped short of a fundamental overhaul of the drugs regulator after April's Health Select Committee questioned its independence.

Medical professors speak out against advertising directly to consumers
BMJ - Jeanne Lenzer
The drug industry's "onslaught of advertising to promote prescription drugs . . . does not promote public health" and "increases costs and unnecessary prescriptions," more than 200 US medical school professors said last week. In the United States the industry spends $4bn (£2.3bn; €3.3bn) a year on direct to consumer advertising.

Serotonin and Depression: A Disconnect between the Advertisements and the Scientific Literature

UK: Crackdown on drug firm promotion
Drug firms will no longer be able to court doctors with prizes and lavish venues, following an overhaul of the industry's code of practice. Companies must only offer economy air travel to delegates sponsored to attend meetings, the Association of the British Pharmaceutical Industry adds.

By Dr. Carolyn Dean, MD, ND and Elissa Meininger
December 1, 2005 -

Big Pharma's Battle Over Direct to Consumer Advertising
By Evelyn Pringle
Big Pharma has Americans running to the doctor demanding the latest advertised drug to treat the latest promoted disorder based on the latest commercial they see on TV. According to a report by CBS News on October 22, 2006, the United States makes up just 5 percent of the world's population, "but it accounts for a whopping 42 percent of the world's spending on prescription drugs — more than $250 billion just last year."

CMAJ * Canadian Medical Association Journal - January 2, 2007
CanWest Media group set to challenge ban on DTCA
(Direct-to-Consumer-Advertising of drug ads)

Last December CanWest, which owns 11 of Canada's major daily newspapers including the National Post, a major television channel and other media outlets, launched a legal challenge to the federal law outlawing American-style prescription drug advertising, claiming that the regulation discriminates against its business interests.

Armed with New Vaccines, Drug Makers Target Teenagers
The fact is, treatments that are proven safe and effective do not need aggressive marketing--word quickly spreads about their demonstrable efficacy convincing doctors to prescribe such medicines--manufacturers don't invest money to market antibiotics--they are a proven commodity. Drug and vaccine manufacturers invest big bucks mostly (if not entirely) to advertise ineffective (or marginally effective, often unsafe) drugs and vaccines. They advertise most aggressively for the first two years before the lack of efficacy and adverse effects become obvious.


posted by Sepp Hasslberger on Monday November 29 2004
updated on Friday December 10 2010

URL of this article:


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