BIG PHARMA at work
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Psychiatric drugs promote mental illness and early daath--Prof. Gotzsche
Shortages in Essential Drugs--Big PhARMA at work
MOST drugs are from China and India
Medical Device Makers cannot be sued, Supreme Court Rules
Ghost writing the norm for over a decade
journal articles are advertising dressed as science--examples
Top 10 Drug Recalls and Warnings of 07
FDA Fraud Program
Big PhARMA ghost writes journal articles
Big PHARMA pays generic manufacturers to not ...
New CANCER drugs add little to life expectancy--why
Big Pharma influences the DSM manual
Most Drugs Now are both Imported and not Tested for Purity
Slash taxes or we move our facilities
RU-486 comes from China, now--more tainted drugs
Antidepressants Proven useless for most
Heart Medication kills 22,000 in 2 years
Statin combination Vytorin doesn't work, etc.
Off Label Drug Pushers
0ff Prescription Market Law Eli Lilly violates for Zyprexa
Price Gouging for Orphan Drugs
Marketing department ran massive drug trial for VIOXX
Direct to consumer spending on the rise
Pharma Lobby and Democrats
U.S. Pharma Moves to China and India
Research and Production moves to China and India
Cancer Generic Drug Shortage increases sales of patented drugs
Direct to consumer spending on the rise

Study: DTC ad spending on the rise

A new study is guaranteed to turn up the heat on direct-to-consumer marketing. Published in the current New England Journal of Medicine, the study shows DTC promotions growing faster than overall drug marketing costs. DTC ad spending has leapt by 14 percent per year since 2002, to $4.2 billion {$5 billion in 06—jk}. By contrast, total promotional spending is up only about 9 percent per year, to $30 billion.  These figures are released by Big Pharma and are not subject to review.  Moreover, most of protional spending is not counted as such, but rather label as educational.   

Meanwhile, the FDA appears to have slacked off on regulating the ads, the study shows. The agency sent 142 warning letters about ads in 1997, versus just 22 in 2006—Bush appointees at work. And, the study notes, a number of the most heavily marketed drugs were blitzed to consumers long before their safety profile emerged from regular clinical use.

Just look at Vioxx and--more recently--Avandia. The Institute of Medicine last year recommended that DTC advertising be limited in the first two years after a drug's regulatory approval to help prevent another safety crisis. Pending legislation in Congress would forego that sort of limit in favor of fines for advertising violations. One bill would allow the FDA to critique ads before they print or air, and if companies made the requested changes, they'd be cleared of liability. House and Senate versions still have to be reconciled, though, so it's anyone's guess whether new DTC regs will make it out of Washington this year--jk.

August 16, 2007



Companies' heavy drug promotion under fire

Thursday, August 16, 2007

By Joe Fahy, Pittsburgh Post-Gazette

Pharmaceutical companies are spending increasing amounts on advertising targeted to consumers, despite concerns that some drugs approved for distribution could later be linked to serious health risks.

A number of heavily promoted drugs were marketed to consumers within a year after their approval by the U.S. Food and Drug Administration, according to the study, published today in the New England Journal of Medicine.

It "takes substantially longer for the safety profile of a drug to emerge," said Dr. Julie Donohue, lead study author and an assistant professor at the University of Pittsburgh Graduate School of Public Health.

The FDA monitors the safety of drugs after they reach the market, but that process has been criticized.

The drug manufacturer Merck pulled the painkiller Vioxx from the market in 2004 after studies found that it was associated with heart attacks and strokes. The FDA also came under fire recently for failing to alert the public to data suggesting that the diabetes drug Avandia may increase the risk of heart attack.  Both drugs were heavily advertised upon their release to the market. Legislation is pending in Congress that would strengthen the monitoring of drugs after their release.

In a report last year, an Institute of Medicine committee spoke in favor of a ban on drug ads targeted to consumers -- known as "direct-to-consumer" advertising -- in the first two years after a drug is approved, though it noted that a moratorium could face legal challenges. At the very least, the group noted, the ads should point out that evidence for risks and benefits is less developed than for older drugs.

In the study published today, Dr. Donohue and other researchers concluded that a ban on direct-to-consumer ads for new drugs "would represent a dramatic departure from current practices."

The study examined trends in spending by pharmaceutical companies on direct-to-consumer advertising and promotions to physicians.  It found that total promotional drug spending grew from $11.4 billion in 1996 to $29.9 billion in 2005.  The greatest share of promotional spending in 2005 was for free medication samples, followed by "detailing" -- visits by sales representatives to health professionals.

A number of academic medical centers, including the University of Pittsburgh Medical Center, have imposed, or are considering, limits on detailing or use of samples.  Direct-to-consumer advertising made up just 14 percent of total promotional expenditures in 2005. But since 1996, that spending increased by 330 percent, the authors noted.  About 85 percent of drug ads targeted to consumers are on television, Dr. Donohue said, noting the drug industry is not required to have FDA approval before running ads.  While industry officials generally are responsive to pulling ads in response to letters from the FDA, those letters tend to be sent after the ad campaign has run its course, she said.

The study suggested that the FDA's capacity to enforce advertising regulations has weakened in recent years. It noted that a Government Accountability Office report found that a legal review required before regulatory letters are issued has led to delays and a reduction in the number of letters.  The study also noted that FDA staffing dedicated to reviewing ads has remained stable even as the number of ads has grown. The share of broadcast ads that underwent FDA review prior to airing dropped from 64 percent in 1999 to 32 percent in 2004.

In a statement, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said the group generally supports legislation that would allow the FDA to hire additional workers to review direct-to-consumer ads prior to their public release. He also noted that pharmaceutical companies spend far more on research and development of new medicines than on promotion.

Surveys indicate that direct-to-consumer advertising "helps start important doctor-patient conversations about conditions that might otherwise go undiagnosed or untreated," he said.

Research indicates that direct marketing to consumers increases the number of people using certain drugs, Dr. Donohue said.  The greater use is not necessarily bad, she said, but noted that critics are concerned about safety and that the prescribing of some drugs can drive up costs. Many Medicare recipients are heavy prescription drug users, and taxpayers are footing part of the bill for the government's Medicare drug program, known as Part D.  Another concern, she said, is that the ads may promote drugs for problems that some might consider less of a priority, such as toenail conditions or erectile dysfunction.

The heartburn drug Nexium was the top drug in direct-to-consumer advertising in 2005, with spending totaling $224 million, according to the study.  Others in the top five were the sleep aid Lunesta, the cholesterol-lowering drugs Vytorin and Crestor, the asthma medication Advair and the allergy drug Nasonex.

Other authors of the study were Marisa Cevasco, of the Harvard School of Public Health and the Vanderbilt School of Medicine, and Dr. Meredith Rosenthal of the Harvard public health school.

First published at PG NOW on August 15, 2007 at 11:27 pm

Joe Fahy can



From In These Times, a monthly magazine of mainly political, labor, and U.S. and international news also available on the internet.  The U.S. is the only country besides New Zealand to allow direct to consumer advertising.  The harm comes primarily from patients, who are less informed than doctors, pressuring doctors to make less than sound medical choices. DTC advertising drives up drug price.


Views > December 20, 2007 at

Warning: Drug Ads Can Make You Sick

A $4.2 billion annual drug industry incessantly reinforces the medicalization of complaints through direct-to-consumer (DTC) advertising

By Terry J. Allen


Jane’s family is suffering from plagues of biblical-lite proportions. Her teenage son is unruly and easily distracted. Her daughter has menstrual cramps, is 12 pounds overweight and shy. Her husband sleeps fitfully and has occasional heartburn and irregularity—not to mention that his libido is falling and his cholesterol rising. As for Jane, her menopause generates more heat than a blowtorch. Her knees twinge, her breasts are less perky and her jaw line more blurred. Her personality is flat and her legs restless. All of them are less happy than they think they should be.

Although there is a diagnosis, pill or surgical treatment for each of their ills, the family members could simply be suffering from exposure to advertising that sells a fantasy of flawless health, perfect skin, clockwork bowels, extended youth and perpetual cheerfulness in the face of disappointment, aging, money woes and the reign of George Bush. They may, in fact, be healthy people snookered by the pharmaceutical industry, the media and their doctors into believing that ordinary frailties are diseases; that the human condition can be cured.

A $4.2 billion annual industry incessantly reinforces this medicalization of complaints through direct-to-consumer (DTC) advertising.

In 1998, the Food and Drug Administration (FDA) decided to allow pharmaceutical companies to hawk prescription drugs to the public, with limited oversight and minimal explanation of safety and side effects. A 2006 Government Accountability Office investigation found some of these marketing efforts “false and misleading” and faulted the FDA—which is responsible for oversight—for failing to maintain standards of accuracy and to protect the public. The United States and New Zealand are the only countries that allow DTC marketing.  {New Zealand in 06 ended this practice—jk}

Big Pharma says that the goal of DTC ads is to educate the public about what treatments are available. But there is no denying that the images of people caressed by soporific green moths, charmed by Latino bees and enticed by sexually fulfilled couples can create expectations and perceived needs that lead to unnecessary and expensive drug consumption. Some of the products are only minimally effective. Many can cause liver or kidney damage, high blood pressure or other adverse effects that would have to be countered with still more drugs—each with its own side effects and risky interactions.

One undeniable side effect of DTCs is increased sales and profits for drug manufacturers. “Every $1 the pharmaceutical industry spent on DTC advertising in 2000 yielded an additional $4.20 in drug sales,” the Kaiser Family Foundation recently reported. Indeed, direct-to-consumer advertising “was responsible for 12 percent of the increase in prescription drugs sales, or an additional $2.6 billion.”

Many doctors act as enablers. A majority of them reported that DTC ads caused patients to “confuse relative risks and benefits” or to believe the drugs “worked better than they do,” according to the FDA. Almost three out of four docs said patients were spurred by the ads to ask for unnecessary prescriptions and to expect a prescription for every condition. Nonetheless, despite feeling pressured and sometimes ambivalent about efficacy, safety and appropriateness, doctors turned down requests for a brand-name prescription only 2 percent of the time, the FDA found.

Americans are swallowing a lot of pills. Spending on prescription drugs is America’s most rapidly increasing healthcare cost and, in 2004, outpatient prescription medications—3 billion scripts worth $200 billion a year—constituted nearly 20 percent of healthcare spending, according to a government survey. Almost half of us take at least one prescription medicine, and one in six downs three or more medications, according to a 2004 Department of Health and Human Services report.

There is something in the American character that loves a quick technological fix, and DTC advertising convinces us that drugs can cure our physical and psychological aches and pains—even our existential crises and obnoxious personality traits. While many people with debilitating depression do find better living through chemistry, there may be something wrong with a definition of normality that classifies one in 10 women, 18 years of age and older, as so clinically depressed that she requires powerful antidepressants. Or a definition of normality that diagnoses 15 percent of 16-year-old boys with attention deficit hyper-activity disorder (ADHD). ADHD drugs make up three of the top five drugs for children age 17 and younger (sales totaling $1.3 billion in 2004). And of the 4.4 million 4- to 17-year-olds with an ADHD diagnosis, more than half were medicated despite what the Centers for Disease Control and Prevention called “substantial health risks.”

The old joke used to be this: A doctor who finds a patient healthy hasn’t looked hard enough. DTC advertising cuts out the middleman and allows the consumer to over-diagnose. It directly exploits the public’s fears and hopes by planting the illusion—and then preying on it—that health, youth and happiness are commodities, and anything less is a disease.



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