Evelyn Pringle November 21, 2006
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."
And yet, when compared to nearly two dozen other industrialized countries, the US has the highest infant mortality rate and the lowest life expectancy for people who have reached the age of 60, according to a September 20, 2006 report by The Commonwealth Fund's Commission on a High Performance Health System.
In August 1997, the FDA relaxed the restrictions on television and radio DTC advertising, permitting drug companies to mention both the name of the drug, and the disease or symptoms that the medication treats in the same ad.
Industry critics say the end result of the easing of restrictions has been massive advertising campaigns that regularly promote drugs for off-label unapproved uses, understate risks and overstate benefits, and make efficacy and safety claims that are not backed up by clinical studies.
The most common strategy used these days to mass-market a drug is "disease mongering" to increase the number of potential customers diagnosed with a new disorder. Big Pharma even hires PR firms to come up with the most sellable names for the disorders.
"At Brand Institute, Inc., a Miami marketing firm," CBS reports, "naming, or re-naming, syndromes for drug companies is 20 percent of the business."
The key, the company's president, Jim Dettore, told CBS, is a name that describes the symptom in a nice way, making it OK to seek help, preferably with the client's drug. "These acronyms allow them to communicate more effectively with less pressure," Mr Dettore said.
Disease mongering through DTC advertising can dramatically increase the sales of just about any product. For instance, Lamisil is used to treat toenail fungus. The main adverse effect of the fungus is that it turns the toenail yellow and it can hurt, but no one has died of toenail fungus.
However, people taking Lamisil have died from the drug, according to "Pill Pushers," in Forbes.com on May 8, 2006, "Federal regulators have linked the drug to 16 cases of liver failure, including 11 deaths."
The Forbes article reports that 10 million Americans have taken Lamisil, at a cost of $850 for a 3-month treatment, even though the drug only cures the problem in 38% of the patients.
The advertising campaign for the drug featured a cartoon character called "Digger the Dermatophyte" being crushed by a giant Lamisil pill.
The ad so overstated the benefits of the drug, Forbes said, that regulators objected and the company was forced to pull the ad. But the campaign was obviously a huge success because in 2004, Lamisil sales increased by 19% to reach $1.2 billion worldwide and held steady in 2005.
Prescription drug advertising has provided a steady stream of revenue for print and broadcast media since the FDA lifted the restrictions. IMS Health, an industry tracking firm, reports that overall in 2004, drug companies spent about $4 billion on DTC advertising.
According to contributing editor, Judy Lieberman, in the July-August 2005, Columbia Journalism Review, the CJR monitored the evening newscasts on ABC, CBS, and NBC for one week in April 2005, and found that network viewers saw an average of 16 ads for prescription drugs and on average 18 commercials for over-the-counter drugs every night.
In 1999, the five networks, including Fox News and CNN, received $569 million in advertising revenue from drug companies, according to TNS Media Intelligence. But by 2004, advertising revenue nearly tripled to $1.5 billion, according to Ms Lieberman.
As far as advertising dollars spent on print media, at the end of 2004, Ms Lieberman found that drug company ads for Time magazine totaled $67 million; $43 million for Newsweek; and the New York Times took in $13 million.
Advertising dollars pay big dividends. A 2003 Harvard Public Health study commissioned by the Kaiser Family Foundation determined that for every $1 spent on direct advertising, drug companies took in an additional $4.20 in sales.
No other drugs in history have received more promotion and media attention than the Cox 2 inhibitors which include Merck's Vioxx, and Celebrex and Bextra, by GD Searle, a company bought later by Pharmacia. Celebrex went on the market in January 1999, and Vioxx was FDA approved on May 20, 1999.
The study, "Promotion of Prescription Drugs to Consumers: A Look at the Numbers," in the February 14, 2002, New England Journal of Medicine, found Vioxx to be the most highly promoted drug in 2000 with Merck spending $161 million.
The only real selling point for the Cox 2 inhibitors was the claim by drug makers that the new medications supposedly did not cause stomach bleeding and ulcers that sometimes resulted after lengthily use of painkillers like aspirin, ibuprofen, and other non-steroidal anti-inflammatory drugs (NSAIDs).
That assertion was untrue and in fact, the FDA refused to allow the companies to make that claim in advertising or the drug's guidelines for use, since it was not backed up by any clinical studies. The package insert that did accompany the new pain relievers contained the same warning as the older NSAIDs.
But never known to let a little FDA warning stand in the way of profits, in no time at all the drug makers had the mainstream press and medical literature flooded with ghost-written articles and press releases with the names of "experts" attached, describing the bleeding problems and deaths caused by NSAIDs, followed by the effectiveness and safety of the Cox 2 inhibitors.
For instance, Vioxx was approved on May 20, 1999, two days later on May 22, 1999, the Washington Post ran the headline, "FDA Approves Pain Reliever with Fewer Side Effects," and article reported that NSAIDs cause "107,000 hospitalizations and the death of 16,500 people every year."
Never mind that the same year, a survey by the Centers for Disease Control reported that less than 6,000 people died the year before from any and all types of gastrointestinal bleeding disorders combined.
However, apparently Merck found a different group of people to survey because on the December 26, 2000, Jim Lahrer News Hour, Dr Roger Perlmutter, who was listed as overseeing basic research at Merck, said, "Each year something in excess of 8,500 deaths and more than 50,000 hospitalizations result from the chronic use of non-steroidal anti-inflammatory drugs."
He claimed that NSAIDs produced dangerous and even deadly side effects in about 4% of patients, including bleeding in the stomach or intestine. "The result," Dr Perlmutter said, "is an increase in ulceration and severe gastrointestinal complications."
At the time of their arrival on the market, Wall Street analysts referred to the launch of the Cox 2 inhibitors as the most successful marketing coup in the history of the pharmaceutical industry.
Drug company sales reps swarmed into medical clinics with free samples galore and millions of patients began demanded prescriptions for the new miracle arthritis pain relievers and sales took off the minute the drugs hit the shelves.
Pain relief drugs that cost pennies a day were history and millions of patients were conned into forking over three to 6 bucks for pills that were no more effective, and as it turns out, much less safe than aspirins.
Reportedly, over 100 million people were prescribed Vioxx and massive DTC advertising has been singled out as the main factor that led to an unusually high number of patients being prescribed the drug before the lethal side effects were known.
In an August 30, 2005, interview with Manette Loudon, career FDA scientist, Dr David Graham said the Vioxx disaster would not have been half as bad if not for DTC advertising. "I submit," he said, "that the numbers would have been far lower than what they were."
Due to heavy marketing of new drugs like Vioxx, Dr Graham says, patients and doctors will often use a drug that is no better than others already on the market, even though the FDA does not require that new drugs be equivalent to, or better than, the drugs that are already there. All they have to prove is that a drug works better than a sugar pill, he says.
Merck finally withdrew Vioxx from the market in September 2004, but not before an "estimated 88,000-140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of Vioxx," according to Dr Graham.
The US national estimate of the case-fatality rate was 44%, he says, which suggests that many of the excess cases attributable to Vioxx use were fatal.
An expert witness in one of the Vioxx trials, the respected biostatistician, Richard Kronmal, from the University of Washington, testified that as early as April 2001, Merck had data that showed a 4-fold increase risk of death in Vioxx patients from a clinical trial that Merck was conducting to determine whether the drug was effective in treating Alzheimer's and yet the company continued the study until 2003.
"They had evidence that they were potentially killing people and they let that trial go on for another two years," he said.
According to Merck, as of September 30, 2006, there are close to 24,000 Vioxx-related lawsuits filed against the company on behalf of over 41,000 plaintiff's groups, and an additional 275 class actions seeking personal injury damages or reimbursement for the costs of buying a drug that Merck misrepresented as being safe and more effective than it actually was.
The Vioxx debacle has placed Merck, the FDA, and the issue of drug safety on center stage and the spotlight is focused on the faulty process by which new drugs are approved and advertised along with the inadequate post approval safety surveillance program.
Lawmakers on both sides of the isle have accused FDA officials of being too cozy with Merck and the over-promotion of Vioxx has led to several pieces of reform legislation aimed at the FDA's lack of regulatory efforts toward curtailing DTC advertising abuses.
On November 17, 2006, the Senate Committee on Health, Education, Labor, and Pensions, held a hearing and gave Democrats their first chance to exercise their muscle to demonstrate how they will deal with the FDA's stance on DTC once they become the majority in Congress next year.
The hearing titled, "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation," focused on Senate Bill 3807, the "Enhancing Drug Safe and Innovation Act of 2006," co-sponsored by committee chairman, Senator Michael Enzi (R-WY), and Senator Ted Kennedy (D-MA), the next chairman of the committee.
A prepared statement from Senator Enzi's office said the Senate Bill will "ensure that drug safety is not an afterthought," and Senator Kennedy said that as chairman, he plans to hold a series of hearings aimed at FDA oversight early in 2007.
Dr Steven Nissen, MD, from the Cleveland Clinic, testified at the hearing and told the panel that the post marketing surveillance system for prescription drugs functions poorly. "Adverse event reporting," he notes, "is voluntary and studies show that only 1 to 10% of serious adverse events are ever reported to the Agency."
And therefore, he informed the committee, "the actual incidence of serious or life-threatened complications cannot be calculated accurately."
Dr Nissen also said that DTC advertising requires legislative action. "The standard for acceptable DTC advertising," he told the panel, "should require demonstration of a compelling public health benefit for this type of communication."
"Drugs with an addiction potential, such as sleeping medication," he said, "should be specifically prohibited from consumer advertising."
As it is now, according to Pill Pushers, by Forbes on May 8, 2006, prescriptions for sleeping pills increased 48% in five years to 43 million prescriptions annually, driven by the DTC advertising of Ambien and Lunesta, and sales in the same period rose to $2.76 billion.
Jim Guest, president and CEO of Consumers Union, publisher of Consumer Reports, testified on behalf of Consumers Union, and asked lawmakers to limit advertising of new drugs for three years, instead of the two year requirement in the Senate bill, because most adverse events do not show up until nearly seven years after a drug has been on the market, he said.
However, a Johnson & Johnson vice president, Adrian Thomas, told the committee that a 2-year moratorium on DTC advertising for newly approved drugs "represents a troubling change."
"Appropriate DTC advertising plays a valuable role in educating patients about diseases and treatments," Mr Thomas told the panel.
"The value of this education to patients," he continued, "as well as important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area."
Mr Guest testified that consumer advertising is not an educational tool, but rather a vehicle to mass market drugs before the serious side effects become known. "The direct-to-consumer advertising," he told the panel, "is not a good way for consumers, physicians or medical providers to be informed."