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Vioxx: major changes needed to improve prescription drug safety

For Immediate Release
Thursday, Nov. 18, 2004
Contact: Janell Mayo Duncan
(202) 462-6262

Consumers Union Calls for Major Improvements in Prescription Drug Safety

Letter to Senate Panel Asks for Public Registry of Clinical Drug Trials, Immediate FDA Action on Misleading Drug Ads

(Washington, D.C.) – Below is a letter submitted today by Consumers Union to the Senate Finance Committee, which held a hearing on why it took so long to remove the prescription drug Vioxx from the market.
The letter includes specific recommendations to help improve the safety of prescription drugs by requiring mandatory public registry of clinical drug trials; clear and specific drug advertisements; immediate FDA action to halt misleading ads; a halt to marketing campaigns for products which have safety questions; and funding of Sec. 1013 of the Medicare Act to study the relative cost-effectiveness of drugs.
To send a free e-mail to Congress supporting these drug safety improvements, Click Here.
Nov. 17, 2004
Dear Senator:
Consumers Union, publisher of Consumer Reports Magazine, commends Senator Grassley for holding the hearing scheduled for tomorrow, entitled “FDA, Merck, and Vioxx: Putting Patient Safety First?” We believe that — especially in light of the recent drug safety concerns surrounding the treatment of adolescents with antidepressants — it is critically important to examine why it took so long for Vioxx to be removed from the market despite many warning signs of unreasonable risks associated with its use.
As you know, on September 30th, Merck withdrew this blockbuster drug from the market based upon concerns that the risks to consumers of heart attack and stroke outweighed the drugs potential benefits to treat acute pain. The drug generated $2.5 billion in sales for the company in 2003. Spurred by a $195 million dollar ad campaign, a reported 84 million prescriptions were written for the drug since its approval in 1999. At the same time, a recent study by FDA reveals that Vioxx likely is responsible for an estimated 20,000 heart attacks or deaths during that time.
Concerns about potential heart risks emerged as early as 2000. In 2001, an article in the Journal of the American Medical Association reported that Vioxx (and Celebrex) appeared to increase the risks of heart attack and stroke. An additional study in 2002 conducted by an epidemiologist at Vanderbilt University found significant risks among patients on high doses of Vioxx. In 2002, although the FDA required additional warnings on the label relating to heart risks, this product continued to be widely advertised and sold – while Merck and the FDA failed to take more responsible action.
FDA’s Proposed Improvements to Safety System
On November 5th, the FDA announced that it will strengthen its system for reviewing drug safety, including: (1) establishing an internal program to ensure the views of dissenting scientists are heard; (2) seeking a review by the National Academy of Sciences of the FDA’s safety monitoring procedures; and (3) conducting a nationwide search to fill the director position at the FDA’s Office of Drug Safety. We believe that this initiative may bring positive change, and urge the Agency to complete these improvements as soon as possible.
Consumers Union’s Recommended Improvements
Some additional improvements needed to improve prescription drug safety and transparency include:
• Requiring sponsors of clinical trials to register their studies before they are begun. Pairing a registry with mandatory disclosure of trial results would create a centralized repository for such information, make adverse information much more difficult to hide, and would give consumers and physicians the information they need as they make important decisions about healthcare;
• Advertisements must be clearly and strictly limited to focusing on the intended patient population. Although Vioxx was approved to treat osteoarthritis, rheumatoid arthritis, and menstrual pain, direct-to-consumer campaigns likely increased the market far beyond the intended patient population – while at the same time Vioxx had not been shown more effective than ibuprofen for pain relief;
• FDA must seek to halt misleading prescription drug marketing immediately. A September 17, 2001, warning letter sent to Merck by the FDA stated that the company engaged “in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed” in a clinical trial comparing Vioxx to naproxen, a less-expensive painkiller. The FDA letter said, “Your promotional campaign discounts the fact” that in the trial, “patients on Vioxx were observed to have a four to five-fold increase” in heart attacks, compared with patients on naproxen. Recently the number of FDA warning letters sent out for violations has dropped dramatically. Misleading ads impact public health because many overstate benefits, understate risks, and lead to consumers to seek out medicines without understanding the drug’s relative risks;
• The FDA should be required to halt marketing campaigns for products for which questions exist about unreasonable safety risks, especially where other alternative products exist with a better safety profile. In addition, where concerns about safety exist, Congress must give FDA the authority to require a company to conduct a study seeking to clarify the extent of unreasonable risks associated with use of the drug; and
• Congress should fully fund Section 1013 of the Medicare Modernization Act, which would enable publicly funded study of the relative cost-effectiveness of drugs. Counteracting the ability of companies to increase demand for a product that may be no more effective than a less expensive prescription or over-the-counter drug would greatly benefit the public health.
We look forward to working with you to improve transparency and prescription drug safety for consumers.
Janell Mayo Duncan
Legislative and Regulatory Counsel
Consumers Union