By Chris Adams

McClatchy-Tribune News Service

WASHINGTON — The question for doctors was simple: “When a patient comes in and asks for Viagra, will you first screen for low T?” meaning testosterone.

The pitch by Solvay Pharmaceuticals Inc. was part of its effort to make its testosterone replacement drug AndroGel “ride (the) coat tails of Viagra.”

But unlike Viagra, AndroGel wasn’t approved by the Food and Drug Administration to treat erectile dysfunction.

Instead, it was approved to treat a relatively specific condition of the sex glands called hypogonadism. According to a significant whistle-blower lawsuit, Solvay wanted to boost AndroGel’s sales with an aggressive strategy to push “off-label” — or unapproved — uses of the drug.

“I can’t underscore enough how important off-label sales were,” said John King, a former sales manager for Solvay who’s involved in the suit. “You can do the math: If we had truly stuck to the FDA-approved indication, AndroGel would never have had anywhere the sales it had.”

While they’re a big part of any drugmakers’ bottom line, such off-label uses also can run afoul of federal drug-marketing laws. It’s legal for physicians to prescribe drugs off-label, often based on their assessment of the latest medical research, but it’s illegal for drugmakers to promote such uses.

The FDA’s regulations on prescription medicine are based on researchers proving the safety and effectiveness of individual drugs for treating specific illnesses. Prescribing drugs to combat illnesses they were never approved to treat can be ineffective and risky to patients.

While off-label marketing long has been commonplace, federal prosecutors in recent years have cracked down on the practice, bringing more than a dozen cases against drugmakers for off-label marketing, and winning billions of dollars in criminal and civil settlements. The cases have revealed how companies and their on-the-ground sales reps ignored drug-marketing laws to convince doctors to prescribe drugs for unapproved conditions. Private whistle-blower suits have been a part of that crackdown.

The current whistle-blower lawsuit actually involves three of Solvay’s drugs — AndroGel, a blood pressure drug, and a mental health drug — and provides an inside look at the world of corporate drug marketing. Although filed several years ago, details in the lawsuits were only recently unsealed at the U.S. federal courthouse in Houston. Dozens of internal company memos, emails and sales presentations were filed in the case, documenting how the company and its sales representatives sweet-talked, cajoled and even paid fees to the doctors in their territories.

AndroGel, a clear gel that men rub on their shoulders, upper arms and abdomen, has been through three corporate owners in the past dozen years: Unimed Pharmaceuticals Inc., which was bought by Solvay Pharmaceuticals Inc., which was in turn bought by Abbott Laboratories. According to Abbott, it has annual U.S. sales of more than $600 million.

The attorneys handling the case said that neither they nor Solvay would respond to McClatchy Newspapers’ questions, other than to note that federal and state governments, which sometimes join similar cases, have declined to do so in this case.

The drug’s current owner, Abbott, said through a spokesman that the case was filed in 2003, nearly seven years before Abbott’s acquisition of Solvay and that, “No specific concerns have been raised in this case about Abbott’s sales and marketing of these products.” Spokesman Scott Stoffel added that AndroGel is approved for the treatment of men with no or low testosterone and Abbott markets AndroGel according to the medication’s label.

Hypogonadism, the condition that AndroGel got the FDA OK to treat, is defined by low levels of the male hormone testosterone, often because of damage — from injury, chemotherapy or other trauma — to the testes. It can result in low sex drive, low energy levels, muscle loss and depression.

How many men suffer from this condition? Those numbers are all over the map.

In 1999, when Unimed asked the government to approve the drug, it announced that hypogonadism was estimated to affect more than “one million American men.”

In 2000, when the FDA approved the drug, the company announced that the market was “four to five million American men.”

But by 2003, when drug was being pushed by its corporate managers, the number drifted to “up to 20 million men,” according to information in the lawsuit.

From the start, Solvay _ which then owned the drug _ wanted to expand the market. In one document, the company noted it needed to expand the testosterone market by 36.5 percent, particularly by pushing the drug to primary care physicians. It sought to convince doctors that low levels of testosterone were widely under-diagnosed, and that conditions associated with normal aging could be because of those low testosterone levels.