Dr. Adriane Fugh-Berman of Georgetown University Medical Center in Washington analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements, many of them using documents from judicial trials.

She said Wyeth, now owned by Pfizer, paid a medical communication company called DesignWrite $25,000 to ghostwrite articles on clinical studies, including four testing low-dose Prempro, the company’s combination estrogen-progestin therapy.

She said the articles were intended to mitigate concerns that hormone replacement therapy raises the risk of breast cancer, and to support the unfounded idea that the drugs offer some protection against heart disease.

Fugh-Berman said DesignWrite was also assigned to write 20 review articles about the drug at $20,000 each. She said the company was expected to promote unauthorized use of the drug to prevent dementia, Parkinson’s disease, vision troubles and even wrinkles.

Use of HRT plummeted in 2002 after the publication of the Women’s Health Initiative study, which found an increased risk of ovarian cancer, breast cancer, strokes and other health problems from hormone therapy.

Sales of U.S. market leader Wyeth’s Prempro have fallen by about 50 percent since 2001 to around $1 billion a year.

“Given the growing evidence that ghostwriting has been used to promote hormone therapy and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” Fugh-Berman wrote in the Public Library of Science journal PLoS Medicine.

A 2008 study in the Journal of the American Medical Association used court papers to suggest Merck had drafted research studies for its now defunct painkiller Vioxx and then went looking for doctors to add their names to the studies before they were published.

From the American Association for Justice news release.

Carol Ernst, whose 59-year-old husband Bob died of heart problems
after taking the drug Vioxx for nine months, must be wondering what it
takes to win a verdict in a damages suit these days.

After Ernst was awarded a $253 million dollar judgment against Vioxx
manufacturer Merck & Co. by an Angleton jury in 2005, the award was
reduced to $26.1 million by the trial judge in accordance with tort
reform restrictions passed by the state Legislature. On Thursday, a
three-judge appellate court panel in Houston found that the expert
testimony presented in the trial on behalf of the plaintiff did not
prove Vioxx caused his death.

The judgment was overturned, and Ernst will receive nothing. She and her lawyer, Mark Lanier, intend to appeal.

Vioxx was taken off the market in 2004 after studies linked the
anti-inflammatory drug to heightened heart attack rates in users. 14th
Court of Appeals Chief Justice Adele Hedges wrote the opinion
acknowledging the validity of those studies, but finding that Ernst’s
expert testimony amounted to conjecture and speculation rather than
proof of his cause of death.

After the ruling, Ernst told Chronicle reporter Mary Flood, "I
trusted if you go to court and tell the truth and the facts are on your
side, the justice system will support you." More and more Texans are
learning that trust is misplaced in a court system inclined at the
higher levels to protect the interests of business over consumers’.

The same day that the Houston court ruled, a New Jersey appeals
court reduced by $13 million a penalty assessed Merck by a jury in a
Vioxx case, leaving $4.5 million in compensatory damages. Also, in a
suit similar to Ernst’s, a San Antonio appeals court tossed out a $32
million jury judgment won by another widow against Merck last month.

In announcing an appeal in the Ernst case, attorney Lanier stated,
"activist judges are protecting corporate executives and stripping away
the rights of widows and every other victim of corporate misconduct.

This decision was handed down by a group of judges who regularly
accept campaign contributions from law firms representing corporations
that appear in their courts.

Given its recent string of court victories, Merck officials are
probably kicking themselves for approving a $4.85 billion settlement
with nearly 50,000 Vioxx litigants that will award each plaintiff about
$100,000.

Rather than encouraging Merck to do what’s right, the 14th Court’s
decision in the case risks emboldening the company to rely on judicial
friends in high places to overrule juries and send widows home
empty-handed.

The settlement announced Tuesday addresses allegations that Merck’s
advertising deceptively downplayed the health risks of Vioxx. New
Jersey-based Merck is not admitting any wrongdoing under the
settlement.

Texas’ share of the settlement will exceed $4 million, Attorney General Greg Abbott said in a statement.

Texas also has an active case in Travis County District Court from 2005
that accuses Merck of suppressing critical information about Vioxx to
doctors, patents and the state Medicaid program, which spent $72
million on Vioxx prescriptions for Medicaid recipients during the
period covered in the enforcement action.

Pennsylvania
Attorney General Tom Corbett says Tuesday’s settlement ends
investigations by 29 states and the District of Columbia into Merck’s
advertising practices involving Vioxx.

The settlement also calls for Merck to submit all new TV commercials for ts drugs to the FDA for review.

Vioxx was taken off the market in 2004 after research showed it doubled
the risk of heart attacks and strokes.

One portion of the proposed agreement has been a big problem for a number of lawyers representing Vioxx plaintiffs. Merck is demanding that lawyers advise ALL their clients to accept the agreement. The obvious problem for the lawyers is that while the agreement might be best for some of the clients, it won’t necessarily be best for all of them. So the lawyer is put in a position of deliberately giving bad advice to some clients — a grievable offense. Here are excerpts from the article:

In an emergency motion with Judge Eldon E. Fallon of Federal District Court in New Orleans, the plaintiffs’ lawyers said the provision would prevent them from offering the best independent judgment for each client. Agreeing to the provision might open them to future lawsuits from disgruntled clients, they said.

“The Settlement Agreement, which allows Merck to dictate the advice a lawyer will offer, is improper in all states,” the lawyers wrote in the motion, which was filed Monday.

Merck and several large plaintiffs’ law firms agreed to the settlement last month as a way to resolve more than 50,000 claims from people who assert that Vioxx, a painkiller that was pulled from the market in 2004, caused them to suffer heart attacks and strokes. Merck had won most of the 18 suits that reached juries in both state and federal court.

The requirement that lawyers agree to recommend the deal to all their clients — and withdraw from representing those who do not agree — is a crucial part of the agreement.

Merck wants lawyers to put all their clients into it so that it will not face the prospect that they will settle their weaker claims while withholding their stronger cases for trial in the future. Merck also wants to be sure that plaintiffs who do choose to go ahead will have to find new lawyers, a process that will probably be difficult because the firms with the most experience in the case are all part of the agreement.

For the deal to take effect, 85 percent of all plaintiffs, as well as 85 percent of plaintiffs who have stronger cases because they took the drug continuously for more than a year, must agree to its terms.

But Benjamin Zipursky, a professor at Fordham Law School who has closely followed the case, said the all-or-nothing requirement might pose ethical problems.

“The question is, is this really independent advice given to each client if the lawyer obligates himself or herself to say this to all the clients,” Mr. Zipursky said.

Mr. Mayer, the Merck lawyer, said the federal court might not be able to change the settlement, since the Vioxx cases were not being tried as a class action, in which any overall settlement requires judicial approval. He declined to say what the company would do if Judge Fallon ordered the two sides to change the agreement.

The motion will be heard in mid-January.

More than 1,000 personal injury lawsuits filed in Texas over the once-popular pain medication Vioxx were put on hold Friday after a judge ruled the drug’s manufacturer had given adequate warnings about the drug.

State District Judge Randy Wilson, based in Harris County, granted a motion by Merck & Co. Inc., the drug’s manufacturer, to dismiss part of a lawsuit filed by Ruby Ledbetter.

Merck’s attorneys argued a 2003 Texas law prevents Ledbetter from claiming she wasn’t properly warned about Vioxx.

The law, passed as part of tort reform efforts, says a drug manufacturer is not liable in allegations it failed to provide sufficient warnings about its product if the drug in question came with warnings approved by the Food and Drug Administration.

Friday’s ruling put Ledbetter’s case, which was set to go to trial in May, on hold.

But Travis Sales, one of Merck’s attorneys, and Tommy Fibich, one of Ledbetter’s attorneys, both said Wilson had previously told lawyers in the case that such a decision would put all Texas cases on hold until appeals courts rule on the issue.

Wilson, who is presiding over all Vioxx lawsuits filed in Texas, said in his ruling that virtually all the Texas cases allege that Merck failed to provide an adequate warning.

"The court got it right," Sales said. "It goes to the heart of what Merck has always said. Merck gave proper information to the FDA and the FDA made proper labeling decisions based on what was there at the time."

Fibich said although the judge ordered an expedited appeal in the case, he thinks that process could still take up to two years to complete. "Meanwhile all those Texas cases will sit there and nobody is going to get their day in court," he said.

Vioxx, an arthritis pain reliever, was pulled from the market in September 2004, when a study showed it could double the risk of heart attack or stroke if taken more than 18 months.

Whitehouse Station, N.J.-based Merck said it now faces 27,250 personal injury lawsuits over Vioxx, including 45,700 plaintiff groups.

The company is sticking by its plan of defending each of thousands of claims over Vioxx rather than settling the suits.

Wilson said in his ruling that for Ledbetter to win her case under Texas law, she would have to show that Merck had withheld or misrepresented information required by the FDA when it approved the drug or that such information was related to her injury.

Wilson said the FDA had not made any determination that Merck withheld or misrepresented information concerning Vioxx.

Sales said federal law pre-empts part of the Texas statute from 2003.

"We think the court looked at this very carefully," Sales said. "Texas courts should not be second guessing the FDA on these issues."

Ledbetter, a 62-year-old woman from Elmendorf, just southeast of San Antonio, suffered a heart attack in May 2004.

"We think the court has made an erroneous ruling," Fibich said. "The effect of his ruling is that it immunizes manufacturers that lie and mislead the FDA."

Fibich said even if appeals courts uphold the judge’s ruling, his client and other plaintiffs have two other claims against Merck they can still try to prove in court: negligence and product design.

"I think they are all three good claims," he said. "If I had to pick just one, it would be the failure to warn claim. But in all the cases where plaintiffs have prevailed against Merck, juries have found in favor of the product design and negligence claims."

Fibich said the case will probably go all the way up to the Texas Supreme Court and he is looking at whether he can file any appeals in federal court.