Merck Admits Little While Settling the Vioxx Case

A week ago, another legal settlement with some noteworthy aspects came marching along.  As reported by the Wall Street Journal, here are the details.

A Guilty Plea to "Misbranding"

First, there was a guilty plea (to a misdemeanor):

Merck & Co. agreed to pay $950 million and plead guilty to a criminal misdemeanor charge to resolve government allegations that the company illegally promoted its former painkiller Vioxx and deceived the government about the drug's safety.

In particular,

The Justice Department said Merck illegally promoted Vioxx for rheumatoid arthritis before that use was approved by the Food and Drug Administration in 2002. The drug was initially approved in 1999 to treat certain types of pain. Drug companies are barred from promoting drugs for unauthorized, or 'off label,' uses, though doctors may prescribe off-label uses.

Merck agreed to plead guilty to introducing a 'misbranded' Vioxx into interstate commerce, which is a misdemeanor violation of the Food, Drug and Cosmetic Act, and to pay a $321.6 million criminal fine.

So the company actually admitted to violating the law in the form of a misdemeanor, selling a drug for unapproved uses. The importance of this sort of activity has been frequently challenged, especially by those who claim that corporations have free speech rights that allow them to promote practically anything they want.

However, this was not the only issue apparently resolved.

A Civil Settlement

The company agreed to pay $628.4 million to settle civil allegations.

What were these allegations?

The government also made allegations against Merck in parallel civil litigation related to Vioxx in addition to the criminal charges.

According to the government, Merck representatives made inaccurate, unsupported or misleading statements about Vioxx's cardiovascular safety, in order to increase sales of the drug. The government also said Merck made false statements to state Medicaid agencies about the drug's safety.

However,

Merck isn't admitting liability or wrongdoing in the civil aspect of the settlement. Mr. Rogers said Merck expressly denies the civil allegations.

'We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx,' said Merck General Counsel Bruce Kuhlik in a statement.

So this is yet another example of a legal settlement made by a health care organization involving that organization paying a fine, but not admitting it did anything wrong.

The Parallel with the Citigroup Settlement

Last week, we wrote about how one US federal judge refused to accept a settlement (in a case of alleged financial misbehavior involving Citigroup) which did not require the company to admit wrongdoing. The judge noted that this presented the logically incomprehensible situation of a company apparently being punished for a reason that is unknown. At that point, one (admittedly outspoken) critic wrote, "This has essentially created a parallel or secret criminal justice system, in which both crime and punishment are adjudicated behind closed doors." Furthermore, these

settlements have evolved into a kind of cheap payoff system, in which crimes may be committed over and over again, and the ... [government's] only role is to take a bribe each time the offenders slip up and get caught.

If you never have to worry about serious punishments, or court findings of criminal guilt (which would leave you exposed to crippling lawsuits), then there’s simply no incentive to stop committing fraud. These SEC settlements simply become part of the cost of doing business....

What No One Had to Admit
In the case of the current Merck settlement, we do know something about the activities that lead to the settlement.  The settlement 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 despite all the evidence of deceptive practices used to market Vioxx as a first-line pain reliever, and all the evidence that Vioxx may have lead to a large number of myocardial infarctions and premature deaths, the US government's settlement with the maker of Vioxx allowed it to deny that its marketers concealed the dangers of the drug.  This shows that the US regulation of health care organizations has been reduced to Kabuki theatre, detached from reality, and in this case, from what appears to be very clear clinical epidemiological evidence. 

As noted above, and by us frequently in the past, as long as the only punishments for bad behavior are fines (paid by the entire organization, not those who authorized, directed or implemented the bad behavior), such "punishments" only modestly add to the cost of doing business, and do not deter future bad behavior.  The continuing bad behavior, indicated in part in the parade of legal settlements we have documented, doubtless leads to much of our health care problems, particularly high costs, poor access, poor quality, and demoralized health care professionals.

Like a broken record (for anyone who remembers what that means), I repeat...   to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.


References


1. 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.

In Michigan, Intentional Alteration of Medical Records is a Felony

I addressed the issue of alteration of electronic medical records and the dearth of truly meaningful penalties at posts such as:

"Stroud v. Abington Memorial Hospital: Is This Why Chart Alteration Might Be Appealing?",

"On Penalties for Alteration of Electronic Health Records"

and

"UPMC and the Sweet death that wasn't very sweet: How EMRs can detract from a clear narrative, and facilitate spoliation and obfuscation of evidence."

A commenter to the latter post led me to another blog where it was pointed out that in Michigan, intentional chart alteration by a healthcare provider is a felony (a criminal act, not just a civil matter), and looks like it has been since the early 1930's.

This would apply not just to paper records, but electronic as well, since the advent of HIT did not alter the essentials of medical record keeping:

Section 750.492a

THE MICHIGAN PENAL CODE (EXCERPT)

Act 328 of 1931

750.492a Placing misleading or inaccurate information in medical records or charts; alteration or destruction of medical records or charts; penalties; applicability of subsections (1) and (2); basis for civil action for damages not created.

Sec. 492a.

(1) Except as otherwise provided in subsection (3), a health care provider or other person, knowing that the information is misleading or inaccurate, shall not intentionally, willfully, or recklessly place or direct another to place in a patient's medical record or chart misleading or inaccurate information regarding the diagnosis, treatment, or cause of a patient's condition. A violation of this subsection is punishable as follows:

(a) A health care provider who intentionally or willfully violates this subsection is guilty of a felony.

(b) A health care provider who recklessly violates this subsection is guilty of a misdemeanor, punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.

(c) A person other than a health care provider who intentionally or willfully violates this subsection is guilty of a misdemeanor, punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.

(d) A person other than a health care provider who recklessly violates this subsection is guilty of a misdemeanor.

(2) Except as otherwise provided in subsection (3), a health care provider or other person shall not intentionally or willfully alter or destroy or direct another to alter or destroy a patient's medical records or charts for the purpose of concealing his or her responsibility for the patient's injury, sickness, or death. A health care provider who violates this subsection is guilty of a felony. A person other than a health care provider who violates this subsection is guilty of a misdemeanor punishable by imprisonment for not more than 1 year, or a fine of not more than $1,000.00, or both.

(3) Subsections (1) and (2) do not apply to either of the following:

(a) Destruction of a patient's original medical record or chart if all of the information contained in or on the medical record or chart is otherwise retained by means of mechanical or electronic recording, chemical reproduction, or other equivalent techniques that accurately reproduce all of the information contained in or on the original or by reproduction pursuant to the records media act that accurately reproduces all of the information contained in or on the original.

(b) Supplementation of information or correction of an error in a patient's medical record or chart in a manner that reasonably discloses that the supplementation or correction was performed and that does not conceal or alter prior entries.

(4) This section does not create or provide a basis for a civil cause of action for damages.

History: Add. 1986, Act 184, Eff. Mar. 31, 1987 ;-- Am. 1992, Act 210, Imd. Eff. Oct. 5, 1992

© 2009 Legislative Council, State of Michigan

I will be giving some attention to try to make this well-deserved penalty the Law of the Land for electronic medical records.

-- SS

"Corruption Kills," So Why Is Health Care Corruption Ignored?

An article published last month by PLoS One(1) emphasizes the stark contrast between the likely impact on health of corruption, including health care corruption, and the attention paid to it. 

The Methodologic Details

The authors performed an ecological, country-level analysis to assess the association of perceived national corruption level (measured by Transparency International's Corruption Perceptions Index [CPI] using 2008 data) and national mortality rates for children under five years old, controlling for the best known measurable predictors of such mortality.   Their final model included the following other predictors: GDP per capita, people with access to improved water source, people with access to improved sanitation, percentage of rural population, literacy rate, dependency ratio, population density, total health expenditure per capita, health expenditure as percentage of GDP, DTP vaccine coverage, measles vaccine coverage, food supply, presence of equatorial, arid, warm temperate and snow climate on national territory, civil liberties, political rights, national battle-related deaths.  The final model had a pseudo R squared = 0.89, and the addition of CPI to the model increased it by 1.61%.

The Results and Implications

The results were that corruption explained approximately 1.61% of the variance of country-level child mortality.  This suggested the hypothesis that:

roughly 1.6% of world deaths in children could be explained by corruption meaning that, of the annual 8.795 million children deaths, more than 140000 annual children deaths could be indirectly attributed to corruption.

The authors emphasized that this was only a hypothesis, and that ecological models are prone to bias. In particular, I would point out that such models can omit variables that are associated with the included variables, but are better predictors, or even true causes of the outcome. Nonetheless, as the authors pointed out, "all the data used in this analysis is the only available to study the problem at this scale."

Another problem is that the analysis could not distinguish the effects of health care corruption from those of other kinds of corruption. In the introduction, the authors emphasized what has been written about the importance of health care corruption as having "pejorative health consequences." However, general corruption could also affect health. The authors gave the example of how corruption could affect access to uncontaminated water.

Nonetheless, the analysis appears highly plausible, and may be the best possible given the available data. It suggests, as the authors noted, that corruption could causes deaths "that largely exceeds the conspicuous pooled total of cholera, rabies, Ebola, and combat-related deaths."

This suggests the big paradox. As the authors put it,

because the equation corruption = deaths is seldom explicit, corruption only seems like a nuisance.

As we have said, most recently here, most of the organizations one might have expected would have provided some response to health care corruption instead have largely treated it as at best a nuisance. Specifically, there is almost no teaching or research on corruption in health care academics (including medical and public health schools, and programs in health care research and policy.)  There is almost no mention of corruption by health care professional associations.  There are almost no initiatives to fight corruption on the part of health care charities and donors.  There is almost no interest in corruption among patient advocacy organizations.  (See previous discussion here.)

Because there is so little interest in and attention to corruption, and particularly health care corruption, there has been little research on it, and therefore the best available estimate of the effect of corruption on health may now be the study by Hanf et al. 

I also postulated that at least in the US context, this lack of interest in corruption may partially be explained by these organizations' institutional conflicts of interest and the individual conflicts of interest affecting their leaders.  It may be further explained by the exposure of some leaders to the irresponsible, if not amoral culture that now currently pervades finance, which may have in turn been one cause of the great recession, or global financial collapse. 

Hanf and collaborators concluded,

The global response to child deaths must involve a necessary increase in funds available to 1) develop water and sanitation access and 2) purchase new methods for prevention, management, and treatment of major diseases killing children around the globe (principally pneumonia, diarrhoea and malaria). However, without paying attention to the anti-corruption mechanisms needed to ensure their proper use, it will also provide further opportunity for corruption. In practice, donors and governments still treat health, water/sanitation access and corruption as separate rather than integral components of the same strategy. To address these obstacles, designing dedicated indicators at micro and macro levels which monitor efficiently corruption impacts on health and heath related services, is urgently needed. Policies and interventions supported by governments and donors must integrate initiatives that recognise how health and corruption are inter-related.

I wonder if the realization that corruption, including health care corruption may be leading to the deaths of children will be enough for academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups to develop "initiatives that recognise how health and corruption are inter-related"?

Reference

1.  Hanf M, Van-Melle A, Fraisse F et al. Corruption kills: estimating the global impact of corruption on children deaths.  PLos ONE 2011; 6: e26990. doi:10.1371/journal.pone.0026990.  Link here.

Health IT Pundits and Perhaps the Most Logically Fallacious (And Even Cold-Hearted) Statement I've Seen About Health IT to Date

The KevinMD blog has reposted George Lundberg's MedPage Today post "Health IT: Garbage In, Garbage Out", retitled as "Health IT has problems, but is worth the price." I covered Dr. Lundberg's original post at my Nov. 16, 2011 essay "George Lundberg, MD: The Promise of Health IT, and a Caveat."

As the KevinMD blog is exceptionally well-read, I expected the HIT pundits to come in with "see no evil, hear no evil, speak no evil" accolades for the technology.

I was right, even early on.

Keep in mind that Dr. Lundberg specifically quotes me in his article:

... However, there is another harsh critic worth listening to.

His name is Dr. Scot Silverstein, and he seems to have made it his life's work to call attention to really bad problems that he discovers in this mass move to automation.

Heed his cautions. They are real.

My writings and opinions are known of by the following pundit, including the fact that my relative was injured as a result of the technology, who commented on KevinMD's reposting of the Lundberg essay. The comment is here (I do not personally know the commenter, only having exchanged numerous back-and-forth comments on a few health IT blogs in the past):

Margalit Gur-Arie [a partner at EHR pathway, LLC and Gross Technologies, Inc. - ed.]

Wow! There's something to be said for extreme statements, whether right or wrong.

... do EHRs kill people? Probably, but every single item used in medicine can be shown to have killed people at one time or another, depending on how you define "killed" [1]. Do more people get harmed where EHRs are present, compared to where they are not? There are no conclusive studies to that effect and there are no conclusive studies showing the opposite either. There are not very good studies at all, but if mass murder was occurring, we would have probably known by now.

The appeal to ridicule and/or argumentum ad ignorantiam-like statement "if mass murder was occurring, we would have probably known by now" is both fallacious and egregious. Is that a criteria medicine uses, in the explicitly admitted situation where conclusive studies are lacking, to promote diffusion of some new treatment or tool? That is, since we don't note catastrophic levels of toxicity, the toxicity is of minor import?

On other logical fallacies, the statement that "every medical intervention can kill", implying that any morbidity and mortality due to EHRs is just a foregone conclusion, is doubly fallacious.

One fallacy is the absolute nature of the statement itself. It isn't true that 'all medical interventions can kill.' Another fallacy is the cavalier lack of distinction between a small vs. large risk of injury or death.

That said, even without considering 1) the literature aggregated here, 2) the context of the IOM Committee on Patient Safety and Health Information Technology's report that states the technology has risks, and worse, that impediments to information diffusion prevent the magnitude of the risks from being known (PDF available here), and 3) the context of my relative's travails, this is perhaps the most wishy-washy, ethically unsatisfying, cold-hearted excuse for health IT's problems -- and for reneging on fixing those problems before national rollouts -- that I have ever seen.

The argument is so bad, it's difficult to parse out the precise nature of all the logical fallacies contained within.

COI disclosure: I note that I have no associations with, receive no payments or royalties from, or have any other relationships with healthcare IT vendors, consultants or customers. I decided to offer my services as an expert witness for attorneys on health IT-related injuries and records tampering as a result of my relative's travails, however.

Note:

[1] "Depending on how you define "killed"? Let me take a stab at that (it should be easier than defining what the meaning of the word 'is' is). How about "resulted directly or indirectly in the termination of all biological functions, as in, the patient's dead?"

-- SS