Healthy Skepticism Library item: 1382

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Consumers Accuse Maker of Hormone Replacement Therapy Drug Estratest of End-Run Around FDA Regulations Seniors Say Company Illegally Sells and Promotes Unapproved Drug at Expense Of Consumers' Health and Pocketbook
PR Newswire 2003 Aug 7

Full text:

A number of consumer groups today filed a lawsuit against Solvay Pharmaceuticals , claiming that the drug maker has engaged in false and illegal marketing of Estratest, a hormone replacement therapy drug the company has been marketing without FDA approval.

The suit, led by the Boston-based advocacy group Prescription Access Litigation project (PAL) on behalf of the 650,000-member Congress of California Seniors and the California Public Interest Research Group (CALPIRG), was filed in California Superior Court in Los Angeles.

The suit alleges that Solvay has been marketing and selling Estratest for the treatment of vasomotor symptoms, or hot flashes, in menopausal women since at least 1981, despite the fact that the drug has never been approved by the Food and Drug Administration (FDA) for that use.

Further, the group points out that in its marketing to doctors, Solvay implies that the drug is not only effective — a claim questioned recently by the FDA — but also is a FDA-approved drug for the treatment of vasomotor symptoms, a direct misrepresentation, the suit claims.

“We have uncovered another situation in which a pharmaceutical company has prioritized profits over patients,” said Ahaviah Glaser, PAL Project Director. “The complaint alleges that Solvay has reaped tens of millions of dollars over the past two decades without following the rules which provide that before a drug is marketed, the FDA must sign off on the safety of the drug, which clearly did not happen here.

The suit is part of PAL’s broadened focus on the marketing practices of the drug industry.

The lawsuit has been brought under California’s Unfair Competition and Untrue and Misleading Advertising laws. It charges that the Estratest marketing materials that Solvay disseminates to doctors imply that the drug is FDA-approved for treating vasomotor symptoms, and make assertions not backed by scientific support.

“The law is very clear — before a drug can be marketed to the public, the FDA must approve it as safe and effective for that specific use,” said Steve Berman, attorney for the plaintiffs and managing partner of Seattle-based Hagens Berman. “Doctors have written more than 34 million prescriptions of Estratest, and many for conditions the drug is not approved to treat.”

In an unrelated patent case in 1999 the FDA, Department of Justice and the presiding judge all reprimanded Solvay for marketing Estratest for unapproved uses, the complaint contends.

According to the consumer groups, these practices have increased sales of the drugs at the expense of consumers who have paid for and taken a drug that has not been proven safe or effective.

“By implying that Estratest is safe and effective for this use, this drug company has taken doctors and consumers for a ride,” said Steve Blackledge with CALPIRG. “We’re standing up to this drug company to stop what appears to be dangerous, arrogant behavior.”

Estratest is a combination therapy, consisting of both estrogen and androgen. In the early 1970s the FDA announced its belief that such combination drugs are effective and safe when used by menopausal women suffering from hot flashes that have not been abated by estrogen-only treatment. At that time, the makers of Estratest and other similar drugs applied for FDA approval of their therapies.

Bill Powers of the Congress of California Seniors points out that the financial impact of the illegal marketing practices of pharmaceutical companies is often devastating to seniors. “Not only are seniors among the greatest consumers of prescription drugs, especially hormone replacement drugs, but they also commonly have to pay for their drugs 100% out-of-pocket,” he said. “High prescription drug prices are eating into any savings seniors have while the drug companies are profiting at the expense of one of our most vulnerable populations.”

Though Solvay applied to the FDA in 1981, Estratest has never been approved for its marketed use. Furthermore, on April 14, 2003, the FDA announced it is investigating whether the combination therapy effectively treats such menopausal symptoms.

Despite its lack of FDA approval and questioned effectiveness, Estratest has proven a lucrative product for Solvay. In 2000, Estratest was the 199th top sold prescription drug in the United States. Sales of the drug reached $110 million in 2001, according the complaint.

Filed in the California Superior Court for the County of Los Angeles, the suit asks the court to order Solvay to immediately stop marketing its product and to issue notices regarding the truth about Estratest’s FDA status. In addition CCS, CALPIRG, and PAL ask that the company be forced to compensate consumers for money spent on the drug and relinquish all profits received from its sale.

For more information about the suit including a copy of the complaint, visit PAL’s Web site www.prescriptionaccess.org.

About Hagens Berman: (www.hagens-berman.com) Hagens Berman is a law firm with offices in Seattle, Boston, Los Angeles and Phoenix. Managing partner Steve Berman was recently named co-lead counsel in litigation to recover losses from Enron employees’ retirement funds. Berman is a nationally recognized expert in class-action litigation. Berman represented Washington, Idaho and 12 other states in lawsuits against the tobacco industry that resulted in the largest settlement in the history of litigation. Berman also served as counsel in several other high-profile cases including the Washington Public Power Supply litigation, which resulted in a settlement of more than $850 million, and the proposed $92.5 million settlement of The Boeing Company litigation. Other notable cases include litigation involving the Exxon Valdez oil spill; Louisiana Pacific Siding; Morrison Knudsen; Piper Jaffrey; Nordstrom; Boston Chicken; and Noah’s Bagels. — Prescription Access Litigation (PAL): (www.prescriptionaccess.org) Since its launch in 2001, the Prescription Access Litigation (PAL) project has filed 17 sets of lawsuits targeting drug industry practices that illegally push the price of prescription drugs beyond the reach of the American consumer. A project of Boston-based Community Catalyst, PAL is on the ground in 34 states and the District of Columbia; the coalition is comprised of 91 state, local, and national senior and consumer health advocacy groups fighting to make prescription drugs affordable.

— Community Catalyst (www.communitycatalyst.org) is a national healthcare advocacy organization dedicated to building consumer and community participation in the decisions that shape our health system. Working in partnership with state, local, and grassroots consumer groups in over 30 states, Community Catalyst has helped preserve over $16 billion in community health assets as hospitals and health plans around the country have become for-profit corporations. It works on a range of healthcare access issues, including today’s struggle to preserve Medicaid services and other health programs amid plunging state revenues nationwide.

— California Public Interest Research Group CALPIRG is a 30-year-old organization that stands up and takes action when consumers are cheated and the voices of ordinary citizens are drowned out by special interest lobbyists. The organization has used the time-tested tools of investigative research, media exposes, grassroots organizing, advocacy, and litigation to protect consumers by encouraging a fair, sustainable economy and fostering responsive, democratic government.

— Congress of California Seniors (www.seniors.org) As an umbrella organization for hundreds of affiliated groups, CCS has a combined membership of over 650,000 Californians. This broad-based coalition includes a variety of senior advocacy organizations such as the California Legislative Council of Older Americans, Gray Panthers, International Senior Citizens Association (ISCA), and Older Women’s League (OWL). In addition, CCS represents retired public employee organizations such as the California Federation of Teachers (ATF AFL-CIO), Retired Public Employees Association (RPEA), California School Employees Association (CSEA), the Retired Division of the California State Employees Association (CSEA), and the California Federation of the National Association of Retired Federal Employees (NARFE).

Member organizations also include the Federation of Retired Union Members (FORUM), as well as retiree clubs representing many trade unions and international labor organizations.