We have written often, and most recently
this week, about the limp posture taken by US law enforcement and regulatory agencies in the face of misbehavior by large health care organizations. At best, official action often results in
legal settlements which let companies pay fines, sometimes large, while the individuals who profited most from the alleged wrongdoing do not suffer any negative consequences. Worse, the legal settlements often allow the companies to continue to deny any culpability, and the legal evidence underlying the settlement, which might let the public at least estimate culpability, is often kept sealed, or confidential. As Judge Rakoff wrote in turning down such a settlement involving a financial, not health care company, sealing evidence hides "
any proven or admitted facts upon which to exercise even a modest degree of independent judgment," and prevents courts and presumably anyone else from trying to determine whether the government endorsement of such a settlement serves any public purpose (look
here).
Keeping Evidence from the Latest Vioxx Case Secret But Ed Silverman,
posting to the revived PharmaLot blog, found an example of how far big health care organizations will go to try to keep secret evidence uncovered during litigation that lead to legal settlements, and how judges other than Judge Rakoff may let them do so.
A federal judge may sanction a physician who served as an expert witness in the ongoing litigation over the Vioxx painkiller for describing confidential documents to The Wall Street Journal.
Earlier this month, U.S. District Court Judge Eldon Fallon issued a restraining order saying David Egilman, who is a Brown University clinical professor of family medicine, 'may have acted in derogation of his responsibilities.' Egilman was an expert witness with access to documents in litigation over the Merck pill that took place in various courts around the country. Vioxx was withdrawn a decade ago over links to heart attacks and strokes.
Fallon, who presides over Vioxx litigation that was consolidated in federal court in New Orleans, had issued an order in 2005 that marked swaths of documents as confidential. Much of the documentation was filed as evidence in litigation in both state and federal courts.
The Nature of the Information to be Kept Secret The post is vague about what secret information Dr Egilman was accused of making public. Apparently, it had to do with his work as
a paid expert witness for plaintiffs in a lawsuit that had been filed by the Kentucky Attorney General, who alleged Merck violated consumer protection laws by failing to disclose to doctors and patients that taking Vioxx significantly raised the risk of a heart attack. The lawsuit was settled last November for $23 million, although the drug maker did not admit to any wrongdoing.
Egilman maintains that some documents demonstrated a failure to properly inform research subjects of side effects and risks, and thus he believes the information should be publicly available.
'In general, there’s information on the toxicity of the drug that’s not been previously published by Merck and there is information that Merck published that misrepresents the health effects of the drug,' he told us three months ago, which prompted the drug maker to complain to the federal judge.
So apparently the information had to do with the possibility that Merck withheld or misrepresented information about the toxicity and health effects of Vioxx. Also, apparently another judge thought that there was at least an argument that this evidence should be public.
What About the Public's Interest? Three months ago, though, a Kentucky state judge permitted Egilman to challenge the confidentiality of the documents, since he had standing as an expert witness which gave him previous access to the materials. As we noted at the time, the judge wrote that 'important public policy questions regarding consumer protection and public health have been raised. The public has an interest in evaluating Dr. Egilman’s opinions and the documents on which they were based.'
Merck appears to be squirming in response to the prospect that this information could become public, and that the public might have an interest, in any sense, in it.
Merck continues to decline comment about the content of the documents and the legal fight with Egilman. But the drug maker argued at a recent hearing that, by virtue of describing the documents to The Wall Street Journal, Egilman violated the 2005 protective order. Moreover, the drug maker maintained that it would be harmed if the documents were disclosed, and Fallon agreed.
While the judge seemed very concerned that Merck somehow might be harmed were to truth to be revealed, it is not obvious either the judge or Merck were at all concerned about the public interest in this truth, if for no other reason than it would say something about what appointed and elected government law enforcement officials are willing to keep secret. Nor did the judge seem concerned about the imbalance for forces obvious when a huge drug company and US law enforcement are on one side, and a single physician is on the other.
Merck's Track Record Vis a Vis Vioxx By the way, while past results do not guarantee future performance, as financial reports are wont to say, past results suggest that Merck was up to no good on a grand scale in its promotion of Vioxx.
As we noted
here, all these settlements arose out of what was called the "Vioxx scandal." In summary, Vioxx (rofecoxib, Merck) a Cox-2 inhibitor non-steroidal anti-inflammatory drug used for pain, and touted for its ostensibly low risk of gastrointestinal side-effects, was withdrawn from the market in 2004 because of its cardiac risks. The Vioxx case is flush with examples of how the company used deception to market a very profitable drug without regard to its risks to patients.
There is evidence is that the company knew about these effects since 2000, but suppressed the clinical research evidence until 2003.(1) In particular, in 2005, the editors of the New England Journal of Medicine raised concerns that an article published in that journal in 2000 about the results of the VIGOR study of rofecoxib sponsored by Merck failed to report data that would have suggested that the drug caused excess cardiovascular risks.(2) In 2007, the company paid more than $4.9 billion to settle patient lawsuits alleging harm due to Vioxx.(3) Also in 2008, the company made a $58 million settlement of claims its advertising of Vioxx deceptively minimized its risks.(4) In 2008, it became clear that at least one apparently clinical trial of Vioxx, the ADVANTAGE trial, was merely a "seeding trial,' that is, a marketing exercise.(5)
On Health Care Renewal, we starting
writing about Vioxx in 2005, including,
-
here about ghost-writing of a Vioxx research publication;
-
here, and
here about allegations that Merck executives tried to intimidate Vioxx critics;
-
here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
-
here about the ADVANTAGE "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
-
here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.
-
here about how in settling a shareholder lawsuit Merck vowed to improve its scientific and academic integrity, and refrain from manipulating and suppressing clinical research.
In 2010, we
summarized the Vioxx case thus, " the Vioxx case provides a
good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case)."
In case there are any doubts about the harms patients suffered as a result of using Vioxx as a pain reliever, in 2004, a cumulative meta-analysis of published trials of Vioxx known by then estimated the risk of myocardial infarction (heart attack) due to Vioxx compared with placebo or other non-steroidal anti-inflammatory drugs was 2.3 times the baseline rate.(6) That analysis suggested that there was data by 2000 that Vioxx increased the risk of bad cardiovascular events. A cumulative meta-analysis from 2009 suggested that the risk of death due to Vioxx was 1.7 times the baseline rate.(7) That analysis suggested there was data by 2001 that Vioxx increased the risk of bad cardiovascular events. Graham and colleagues' nested case-control study of Vioxx use in a large managed care organization lead them to estimate that "88 000 - 140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market-life of rofecoxib."(8).
Yet after all that, Merck is still trying to hide evidence from Vioxx litigation, and a federal judge and apparently federal prosecutors are willing to go along, opposed only by Dr David Egilman
SummaryWe have long talked about what we have called the
anechoic effect, how inconvenient truths that might reflect badly on the current health care status quo and especially those insiders who are making so much money from it are treated as recent unpleasantness that one just should not talk about. The anechoic effect does not arise merely from politeness, or desire not to discomfit the powerful, but from active measures the powerful take to keep dissent down. Here we have an example of a huge drug company, apparently helped by US law enforcement and US courts trying to keep truths about how it marketed a drug out of the public eye, even after so much information suggesting that its marketing was deceptive and unethical, and lead to patients dying has come out.
As we have said endlessly, until health care professionals, policy makers, and the public can obtain and openly discuss information about health care dysfunction, even if that information and its discussion may threaten those who lead health care and make so much money doing so, health care dysfunction will continue. True health care reform would improve transparency and put an end to the anechoic effect.
DisclosureNote that both Dr Egilman and I are voluntary faculty at Brown, although we do not directly work together.
References1. Topol EJ. Failing the public health - rofecoxib, Merck and the FDA. N Engl J Med 2004; 351: 1707-1709. Link
here.
2. Curfman GD, Morrisey S, Drazen JM et al. Expression of concern reaffirmed. N Engl J Med
2006; 354:1193. Link
here.
3. Charatan F. Merck to pay $5bn in rofecoxib claims. Brit Med J 2007; 335: 1011. Link
here.
4. Charatan F. Merck to pay $58m in settlements over rofecoxib advertising. Brit Med J 2008; 336: 1208-1209. Link
here.
5. Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Ann Int Med 2008; 149: 251-258. Link
here.
6. Juni P, Nartey L, Reichenbach S et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; 364: 2021-2029. Link
here.
7. Ross JS, Madigan D, Hill KP et al. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med 2009; 169: 1976-1984. Link
here.
8. Graham DM, Campen D, Hui R et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005; 365: 475-481. Link
here.
ADDENDUM (19 June, 2014) - See also
comments on the 1BoringOldMan blog.
