Edwards Campaign Press Release - Edwards Introduces Proposals To Stop Misleading Drug Marketing By Standing Up To Drug Companies

Instead of defending healthcare lobbyists and drug companies, Edwards is standing up for the American people as part of seven-day "Stand Strong" campaign

Manchester, NH – Arriving in New Hampshire today as part of a seven-day "Stand Strong" campaign, Senator John Edwards introduced proposals to stand up to drug companies to stop misleading drug advertising.

"The excessive costs of prescription drugs are straining family budgets and contributing to runaway health care costs," said Edwards. "Since the government relaxed direct-to-consumer advertising rules in 1997, drug ads have nearly quadrupled to over $4 billion a year.

"With such aggressive and often misleading drug company marketing, it's too easy for advertising – instead of doctors or proven results – to influence families' health decisions. But the FDA has been an ineffective watchdog, reviewing only a small fraction of ads. It's time to stand up to the drug companies and their lobbyists who have rigged the system. It's time to stand strong for families, patients, and doctors."

Edwards believes that new drugs should succeed by treating patients well and cost-effectively, not through lobbying and public relations efforts. To improve the quality of care and bring down drug costs, he will:

• Delay New Ads to Put Safety First: Edwards will institute a two-year delay on consumer advertising of all new drugs.
• Get Control with Real Oversight of Advertising: Edwards will give the Food and Drug Administration real power to prevent misleading drug ads by requiring the agency's approval before drug companies can launch major ad campaigns and by increasing the penalties for drug companies that violate truth-in-advertising laws.
• Require "Whole Truth" Disclosures: Edwards will improve drug makers' disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives.
• Help Doctors Make Decisions Based on Evidence, Not Ads: Edwards will establish a non-profit or public organization to research the best methods of providing care.

Edwards' proposals to stop misleading drug advertising build on his plan to provide universal health care for all Americans. Edwards was the first presidential candidate to propose a plan for quality, affordable health care for every man, woman and child in America. Under his plan, the government will make insurance affordable through new tax credits and by leading the way toward more cost-effective care. Businesses will cover their employees or help pay their premiums. New regional "Health Care Markets" will give individuals, families and businesses purchasing power and a choice of quality plans, including one public plan. Finally, once these steps have been taken, all American residents will be required to take responsibility and get insurance.

Edwards would pay for these reforms primarily by repealing the Bush tax cuts for families making more than $200,000 a year. And to ensure that health care reform is a legislative priority, Edwards will submit legislation on the first day of his administration that ends health care coverage for the president, all members of Congress, and all senior political appointees in both the executive and legislative branches of government on July 20th, 2009 unless universal health care legislation that meets four specific, non-negotiable principles has been passed by that date.

During the week-long "Stand Strong" campaign, Edwards is traveling across Iowa and New Hampshire to discuss his bold and detailed proposals for health care reform, smart and safe trade policies, ending the war in Iraq and restoring America's moral authority in the world. One of the highlights of the week was a major policy address he gave on Friday in Des Moines on corporate responsibility. Edwards called for updating the social compact with hard-working Americans to protect them from abuse by corporations and help them achieve financial security in the new economy.

"Real strength comes from standing up for the millions of American families who don't have a voice," said Edwards. "We need a leader in the White House who has the strength and courage to stand up and fight for regular Americans rather than someone who defends the lobbyists that are destroying the better America we all believe in."

Further details of Edwards' proposal for "Standing Up to Drug Companies to Stop Misleading Drug Marketing" are included below.

Standing Up to Drug Companies to Stop Misleading Drug Marketing

The high cost of prescription drugs are contributing to runaway health care costs that strain family budgets and make American businesses less competitive in the world. Aggressive, often misleading drug company marketing is increasingly influencing families' health decisions. Since the government relaxed direct-to-consumer advertising rules in 1997, the ads have nearly quadrupled to over $4 billion a year. Advertising spending has grown twice as fast as drug companies' spending on research and development. Meanwhile, prescription prices have risen three times faster than inflation and doctors sometimes prescribe name-brand drugs despite the availability of equally effective, less expensive generic drugs. [GAO, 2006; KFF, 2007]

John Edwards believes patients should receive the drug that is most appropriate and cost-effective for them, based on the medical science and the recommendations of their doctors. As president, he will stand up to drug companies and get control over our dysfunctional health care system.

• Contributing to Rising Prescription Drug Costs: Prescription drug spending is rising, and researchers attribute at least 12 percent of increased sales to direct-to-consumer advertising. The price of drugs has also skyrocketed, up an average of 8 percent a year since 1994. Brand name prescriptions average $111 today, triple the price of generics. Since the mid-90s, Americans' prescription use has increased by over 50 percent, to an average of 12 per patient. [KFF 2003, 2007]
• Impact of Heavy Advertising: Top companies spend twice as much on marketing and administration as they do on research and development. It works: every dollar of advertising increases prescription sales by $4.20. Doctors report that pressure to prescribe name-brand drugs raises costs, strains doctor-patient relationships, and can lead to unnecessary prescriptions. [Families USA, 2007; KFF, 2003]
• Promoting Ineffective and Even Dangerous Drugs: It is too easy for heavy advertising—not results—to influence treatments. The intestinal drug Zelnorm was less than 10 percent more effective than a sugar pill, but its memorable ad campaign showing writing on women's bare waists drove 500,000 Americans to buy it. After months of heavy marketing and nearly $1 billion in sales, it was withdrawn for causing heart attacks and strokes. And the controversial COX2 class of pain killers—which includes recalled drugs Bextra and Vioxx—were some of the most heavily promoted drugs in history. [CAP, 2007, NYT, 3/31/07; San Francisco Chronicle, 2/27/2005]
• Ineffective Watchdog: The Food and Drug Administration reviews only a small fraction of ads, voluntarily submitted by drug companies with no requirement of pre-approval. FDA delays result in more than half of misleading ads going off the air or out of circulation before the companies receive a warning. In 2004-2005 it issued only 19 regulatory letters about misleading ads and they came an average of 8 months after the ads began. [Consumer Reports, 2003; GA0, 2006]
• Heavy Washington Lobbying to Protect Billions in Profit: Last year, the ten largest pharmaceutical companies posted a 21 percent profit margin, compared to 8 percent for entire Fortune 500. Drug companies have influenced Washington to protect these profits, spending over $1 billion lobbying and $67 million in campaign contributions since 2000 on their legislative priorities – including successfully fighting tougher advertising restrictions in the recent FDA bill. [CAP, 2007; Boston Globe, 7/31/07; OpenSecrets.org, 2007]

Edwards' Plan to Stop Misleading Drug Ads

John Edwards believes that new drugs should succeed by treating patients well and cost-effectively, not through lobbying and public relations efforts. To improve the quality of care and bring down drug costs, he will:

• Delay New Ads to Put Safety First: Often, serious safety issues appear only after a drug has hit the market. Edwards will institute a two-year delay on consumer advertising of all new drugs, as recommended by the Institute of Medicine and the American Medical Association. A delay will ensure that well-informed doctors – not high-paid advertising consultants – drive prescriptions in the early phases before Americans know the full effects of new drugs.
• Get Control with Real Oversight of Advertising: Edwards will give the Food and Drug Administration real power to prevent misleading drug ads by requiring the agency's approval before drug companies can launch major ad campaigns. He will also increase the penalties for drug companies that violate truth-in-advertising laws.
• Require "Whole Truth" Disclosures: Edwards will improve drug makers' disclosures to the public, requiring companies to tell the public the whole truth about side effects and how effective drugs are against placebos and existing alternatives. As a result, drug companies will no longer be able to advertise costly "me-too" drugs without disclosing the existence of less costly alternatives. He will also require drug companies to disclose foreseeable side effects from implants of medical devices, which are not disclosed today.
• Help Doctors Make Decisions Based on Evidence, Not Ads: Edwards will establish a non-profit or public organization – possibly within the Institute of Medicine – to research the best methods of providing care, drawing upon data from Medicare and the Health Care Markets and medical experts from across the nation. The center will perform head-to-head testing of drugs, as well as devices, to see which work best for specific conditions and populations. It will quickly and widely disseminate its unbiased, scientific findings to physicians and patients. In addition, the FDA will require drug companies to conduct head-to-head testing prior to approving new drugs.