Christopher Lane Ph.D.

Side Effects

Higher Penalties for Big Pharma: Data Destruction Alleged

When will drug-makers end their worst practices?

Posted Apr 13, 2014

Last week, a federal jury in Lafayette, Louisiana, ordered drug-makers Takeda of Japan and Eli Lilly of the U.S. to pay a record $9 billion in damages for hiding evidence of a possible link between their Actos drug and bladder cancer.

According to Andrew Ward in Friday’s Financial Times (late-edition), the fine “set a new bar for drug industry penalties—three times higher than the previous record $3 billion U.S. fine paid by GlaxoSmithKline for marketing abuses in 2012. Analysts say the amount is so high that it is almost certain to be reduced by a judge and could yet be overturned on appeal—Takeda and Eli Lilly insist Actos is safe and have vowed to ‘vigorously challenge’ the verdict.”

During the trial, according to Ward's “Big Pharma: Storehouse of Trouble” (behind a paywall), in a scene that could be straight out of the film Erin Brockovich, “jurors heard how Takeda destroyed large volumes of documents related to Actos.” The prosecutor, Houston-based Mark Lanier, alleged a “reckless disregard for patient safety,” telling the FT afterwards: “It was a cesspool of rotten behavior. The jury wanted to send a message, loud and clear, that it is not acceptable.”

“During the two-month Actos trial,” writes Ward, “Mr Lanier produced emails in which Takeda executives urged colleagues to persuade the US Food and Drug Administration there was no need for a warning about bladder cancer, despite trials having shown a possible link. One said: “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally.”

It’s a statement with variants that repeat throughout the history of pharmaceuticals. As I discovered when researching how drugs were marketed in the 1990s for the treatment of Social Anxiety Disorder, GSK, maker of Paxil, knew about that antidepressant’s serious discontinuation problems months before presenting it for FDA approval—long before it was forced to add a black-box warning about increased suicide ideation and pay out record fines for the deception. In its own language, the company used “highly skilled sales and marketing efforts” to tilt the issues. Efforts included "managing the discontinuation” problem by touting negligible clinical results and minimizing well-documented side effects and withdrawal symptoms.

Stress the drug’s “flexibility and control,” a confidential inside-report advised, and spin the problem of reaction and discontinuation by “putting the problem in context” with “carefully selected data.” The same research took me to newspaper articles bearing titles such as “Sales Reps Told Not to Divulge Paxil Data: Drug Maker Memo Cited Risks to Youth” (New Jersey Star-Ledger, September 2004) and “Despite Vow, Drug Makers Still Withhold Data” (New York Times, May 2005).

A decade later, and it’s still a case of the more things change, the more they stay the same: “At first glance,” Ward asserted last Friday,

there was no direct connection between the Louisiana verdict and the other embarrassing headlines [concerning the pharmaceutical industry]: a bribery probe against GSK in Iraq; a competition inquiry against Novartis and Roche in France; and a report claiming that Roche’s costly Tamiflu antiviral medicine was not proved to be better than aspirin.

Yet all of them, in one way or another, support the claims of industry critics who say big pharma puts profits before public health—from cherry-picking clinical trial data to conceal health risks to bribing doctors and blocking cheaper medicines.

“We should be known for saving lives not falsifying data and bribing doctors,” says Trevor Jones, in something of a classic. Jones used to head the industry’s UK lobby group.

“This pressure [for accountability] is not going to go away,” adds another senior industry figure quoted in Ward’s article. “There is a move towards greater transparency in all areas of society. It is impossible to resist.”  Follow me on Twitter @christophlane