A Senate Bill To Unseal Secret Pharma Documents
19 CommentsBy Ed Silverman // May 19th, 2011 // 11:35 am
For all the intriguing evidence that emerges from product-liability litigation about potential hazards of different medicines, still more documents are often kept under wraps. Why? Drugmakers often succeed in convincing judges to issue protective orders so that certain info - sometimes labeled as trade secrets - remains sealed. And attorneys for plaintiffs generally agree in order to advance the cases.
However, the tactic has long riled critics who say select and crucial safety info may never reach the public. And so the US Senate Judiciary Committee today voted 12 to 6 to approve the “Sunshine in Litigation Act,” which would require judges to consider public health before granting a protective order or sealing court records and settlement agreements. You can read the text here.
“These court-sanctioned secrecy agreements prevent government officials or consumer groups from learning about defective and dangerous products that can stay on the market unchallenged,” says Herb Kohl, a Wisconsin Democrate who chairs the committee, in a statement. The bill is a “response to dozens of cases in which hazards and threats to public health were not disclosed during court settlements and subsequently resulted in additional fatalities, serious injuries or illnesses.”
He cites two examples. A federal judge in Orlando, Florida must decide whether AstraZeneca can keep under seal clinical trials about harmful side effects of its Seroquel antipsychotic. Lawyers for plaintiffs and Bloomberg News sued to force the drugmaker to make public documents that were discovered in dismissed lawsuits. Two years ago, Kohl says, the court unsealed some documents, but denied requests to release AstraZeneca’s submissions to foreign regulators and notes between sales reps and docs. Despite a recent $69 million settlement, “crucial documents,” he says, remain sealed.
Another example: In 2005, Eli Lilly settled 8,000 cases related to its Zyprexa schizophrenia pill and which alleged the drugmaker failed to disclose side effects such as weight gain and diabetes. Lilly was also accused of off-label promotion by urging docs to prescribe the med to elderly dementia patients. All settlements required plaintiffs “not to communicate, publish or cause to be published…any statement…concerning the specific events, facts or circumstances giving rise to (their) claims.” However, no one learned about the settlements or side effects until the documents, which were under a protective order, were later leaked to The New York Times (read here, here and here).
One critic of protective orders cheered the committee vote. “This is one of the ways to stop drug scandals. At this moment, there are tens of thousands of court documents under seal in various cases, including Glaxo and Paxil, that are important for knowing about the dangers of the drugs,” says Paul Thacker, an investigator with the Project on Government Oversight, a non-profit watchdog, and a former investigator for US Senator Chuck Grassley. “The judges keep these under seal and so they don’t become public. There are hundreds of pages of incriminating documents on the ghostwriting Glaxo had for Avandia. We released some of the documents in letters to the NIH, but we know there are more that are under seal.
“This bill would make important safety information public instead of remaining lost forever, which is what happens all the time. The problem has been that it’s not in the interest of anyone involved right now to have it unsealed. For the plaintiffs attorneys, there’s no incentive for them to make the stuff public, especially once their cases are settled, because then they’re done. And the companies want this hidden. And there’s no incentive for judges who just want to move their dockets along. But we’re talking about extermely broad protective orders that are issued.”
UPDATE: We sought a reaction from David Egilman, an expert witness in litigation filed against drugmakers and a clinical associate professor in the department of family medicine at Brown University, who leaked the Zyprexa documents. Here is what he said: “What’s sealed is often critical public health information that, when revealed, saved lives and could save lives in the future. The conduct of pharmaceutical companies has clearly not been changed by anything that’s happened. It’s never been clear to me, at all, why any of the information claimed as a trade secret is a trade secret. The drugs are patented. The method of making the drugs are also often patented, and thus are in the public domain. So the main things they claim as trade secrets are medical information that shows the companies know the drugs harm people and don’t want people to know. While it may hurt their business, the fact that the same information may be hurting patients using their drug or devices should take priority over their trade secrets.
“The other documents show how they conduct off label marketing, which is illegal, and induce the use of their drugs by paying bribes and kickbacks. These are not legitimate trade secrets in that all of the companies are aware of these methods and many of them use the same methods. Many made settlements or pled guilty to off-lablel marketing, so it’s hard to argue such methods are trade secrets, since these are well known to the industry.
“Essentially, they’re claiming the specific methods they use to lie, cheat or steal, are trade secrets, since the drugs and health studies they use to support their methods are public information. For example, many companies pled guilty to misrepresenting the benefits of their drugs. Those are lies. Many companies have been caught cheating in their marketing. And many companies have been caught stealing by overcharging federal and state entities for their drugs. It’s akin to a bank robber claiming that his technique for cracking locks on safes is a trade secret.”
gag thx to erix on flickr
MsPiggy
“AstroZeneca’s submissions to foreign regulators and notes between sales reps and docs. Despite a recent $69 million settlement, “crucial documents,” he says, remain unsealed.”
Is that a typo? besides AstraZeneca being spelled incorrectly…did you mean “remain sealed or under seal” instead of unsealed?
MsPiggy
The kicker for those hoping to view these sealed documents!
SEC. 3. EFFECTIVE DATE.
The amendments made by this Act shall–
(1) take effect 30 days after the date of enactment of this Act; and
(2) apply only to orders entered in civil actions or agreements entered into on or after such date.
Insider
As far as I know ,none of the documents from the Pfizer case are sealed. THe judge was not very happy with the end of that case if you happend to read what he said. That happens to be public record. THe states all have their own rules on releasing documents
Paul
This is not “public health interest” but the same effort by critics to embarrass and impede many proper and legal activities they just don’t like.
Enough…go after the defense or oil industries!!
MsPiggy
“denied requests to release AstroZeneca’s submissions to foreign regulators and notes between sales reps and docs”
Paul I can see you are a big pharma apologist; but this is a huge “public health issue”; if pharmaceutical corporations are giving conflicting &/or omitting pertinent information about a drugs’ safety aka side effect profile to other countries and regulatory bodies, then it’s a serious public health issue.
In AstraZeneca’s case they were warning Japanese regulators about weight gain, diabetes, and metabolic issues related to seroquel while at the same time denying or underplaying those issues to America regulators, health care professionals, patients; all the while marketing the drug off label by every dubious means possible.
So it’s not enough already! We have a very long way to go before this industry can slither away and start claiming they are being treated unfairly.
Bobby
This is an exciting development. Of course, it’s too late for the thousands killed and maimed by the drugs mentioned in this post, but would be a fitting memorial if the bill can be passed. Long overdue, and hats off to Senator Kohl.
Let’s hope that the Senate steps up to the plate with this one and passes it with no nay votes. It’s truly a no-brainer and in the best interests of the American public. Perhaps it might even have some effect on the egregious behavior of pharma, though this is a stretch.
Salient point
Right. So this is going to go to the Senate floor, survive a filibuster, get voted on, pass, go to the House (which is controlled by the other party of course), get passed there, be signed into law & then survive the inevitable challenge that it violates the separation of powers doctrine–which will be determined by the very branch whose powers are being encroached upon.
What are the chances of this happening? 1000:1? 10,000:1?
Evelyn Pringle
Like Salient above, I’m a little more than skeptical about whether this bill will ever come to pass. I can’t even count the times that this same issue has come up since I started investigating Big Pharma in 2004.
Forgive me if I don’t believe it until I see it.
Bobby
After checking back on earlier efforts to get this bill through, my enthusiasm level has gone down. Looks like a real long shot.
Too bad for the Americans killed after documents were sealed. Too bad for the ones who will be killed in the future. Unless Congress wakes up and does the right thing.
Insider
The states have already passed similar laws so I don’t see why the feds can not [pass the law also.
Larry Bone
The problem with the feds passing this is that Representative Ron Paul is the only member of the House that would vote for it and seems like no one in the Senate would support it. Tea party Conservatives might support it but it is not at the top of their list. I think there should also be a bill to compel the unsealing of school shooter medical records that have been sealed by a judge. The public needs to have access to information that will enable to make an informed decision about whether they should or they should allow their children to have to SSRI drugs. Or whether they should take their kids out of a school where too many of the kids are on SSRIs.
Gassa
Information about every kind of drug is available to everybody at the FDA site — one only has to read it. And parents have a responsible to read and become informed before they have their kids use any kind of medication. Even the over-the-counter kind, like Claritin or Benadryl.
And any school that releases the private health information (of any kind) of students would be in violation of all kinds of Federal statutes.
Jon
If the FDA would do the job it was supposed to do, that would be a start. This bill, if passed, will help some yet it is a bit of closing the barn door after the horse gets out. Too bad the industry is so crooked, and too bad the FDA is so (deliberately) weak.
Larry Bone
Clearly information needed to determine the safety or lack thereof of SSRIs IS NOT available because the FDA doesn’t have or get all the information. Why make such a blatant misrepresentation? Legislation is needed to legally and validly overturn Federal statutes that enable the medical records of school shooters to be sealed.
Ted
LOL, Paul. Just LOL. HAHAHAHAAAA! You’re too funny.
Larry Bone
If all the critical information necessary to determine whether a given psychotropic drug is dangerous were readily available from the FDA clearly we wouldn’t need a a Senate Bill to Unseal Secret Pharma documents.
Gassa
What do we have “all” the critical information on? Nothing. So, to apply that standard is meaningless.
However, information about known adverse side effects on all classes of drugs is on the package inserts, which you can read on the FDA site. That’s why it’s important to read this stuff before you take any kind of medicine including over the counter stuff.
Gene Semon
Regardless of the odds, bills like this are worth fighting for.
Big Pharma keeps secrets because they know that their PR pseudoscience on the efficacy and safety of most of their drugs is ultimately indefensible in fair and open scientific discourse.
For the long haul:
It should be obvious that the paradigm of corporate-lawyer based science, as practiced by the pharmaceutical companies, is not going to change overnight.
This is war folks, and Big Pharma is not about to surrender their power over governments.
So we should examine our own rationalizations for inaction.
Just some thoughts from a citizen concerned about the end of our constitutional self-government.
Cara
Should we be wondering also what is happenning on the vaccine front? I’m sure there are loads of side effects that pharmaceutical-vaccine manufacturers would love to keep hidden. Oh I forgot, they already have immunity from litigation if and when their vaccines injure or kill. Can you imagine the public outcry if vaccine cases were “unsealed” but nothing could be legally pursued ?