Friday, January 12, 2018

Pharmaceutical research, Wall Street and financial crime

 Black Edge_ Inside Information, Dirty Money, and the Quest to Bring Down the Most Wanted Man on Wall Street

Today I would like to recommend a book on finance, on one of the largest financial crimes up to now. It is the case of insider trading at SAC, where they plead guilty and a settlement was achieved after paying $1.8 billion. In Black Edge you'll understand better how some hedge funds have been trading on private information rather than with stocks. You'll know how research-physicians received more money from Wall Street rather than from their own salary. And specially you'll understand how the case of bapi by Elan-Wyeth evolved with plenty of details.
I have insisted in this blog that short selling strategies should be banned. This book provides an excellent argument for it. The incentive for insider trading in pharmaceutical research is huge, and those that are able to get short earlier when there are bad news, get the most!
Some statements from the epilogue:
The financial industry has evolved to be so complex that large parts of it are almost  completely beyond the reach of regulators and law enforcement. Wall Street’s most  successful enterprises are constantly pushing into the frontier; every time the law looks like it’s catching up, they move farther away. There is a perception that in the years after the Milken era, and especially since the financial crisis of 2008, it has become almost impossible, due to a lack of will or expertise, to prosecute corporate criminals who operate at the highest levels. The fear of suffering embarrassing losses after long,  expensive trials has led to a kind of paralysis in law enforcement. The Justice Department was unable, or unwilling, to bring any senior Wall Street figures to face criminal charges for the widespread fraud that swept the financial system prior to 2008. Instead, it extracted billions of dollars in fines from the world’s largest banks.
The hedge fund industry created unprecedented fortunes for a new generation of Wall Street traders whose primary innovation was to find ways to make more aggressive bets in the stock market. Cohen was a pioneer, the creator of a trading empire designed to gain an edge over less sophisticated investors. Years later, after paying the largest fines in the history of financial crime—and seeing a dozen of his employees implicated in insider trading—Cohen emerged from the crisis that engulfed his company as one of the world’s wealthiest men.

Wednesday, January 10, 2018

Alcohol regulation as a public policy issue

Alcohol, Power and Public Health: A Comparative Study of Alcohol Policy

Nowadays, I would say that Alcohol Policy this is one of the most difficult and curcial issues in public health. Our societies have internalised its consumption without addressing its risks and the power between industry and regulators is absolutely unbalanced.
A new book that compares the situation in 5 countries is really welcome. Our country is leaving this policy for tomorrow. I would suggest a close look, just for inspiration. Maybe someday it will be the right time.
In particular, change to the alcohol policy status quo requires the convergence of various factors:
  1. For alcohol harm to emerge as a significant, and visible, social problem. This means not only a raised public and political awareness of alcohol harms, but a degree of consensus in framing those harms as a particular type of problem. This, as we have seen, is often driven by concrete social change – especially increases in the amount of alcohol consumed in a given society. However, it also implies the successful framing of a problem by advocacy coalitions, often relying on the development of a more or less compelling body of scientific evidence, as well as external sociopolitical factors (such as, for instance, the crisis of the First World War in Europe) that force the political issue and place the public spotlight on alcohol as a social problem in need of tailored political solutions.
  2. For proponents of change to convince sufficient relevant stakeholders of the validity of their solutions to the putative problem. These include the scientific community, key policymaking networks, influential sections of the media, and so on. As we have seen, for alcohol policy advocates, this means not only winning the argument that alcohol harms exists on a continuum, but also that the line of justifiable intervention is some distance below that commonly understood as ‘dependency’ or limited to those who behave badly when drunk.
  3. For the proposed policy actions to chime sufficiently with the prevailing political context. That is, for policymakers not only to accept the diagnostic and political arguments but, crucially, to decide that implementation of the proposed solutions is politically viable, realistic, consonant with both the ‘national mood’ and internal party politics, and – of course – capable of withstanding resistance from opposing interest groups.
Sounds obvious, but first steps should be well grounded. Current hypocritical attitude should be overcome.

Wednesday, January 3, 2018

Regulatory uncertainty in "home-brew" lab testing

Laboratory-Developed Tests: A Legislative and Regulatory Review

In vitro diagnostics regulation requires continuous adaptation to technologic innovation. Unfortunately, there is a lack of understanding that such a crucial task should be performed efficiently. Europe has waited 23 years for a new regulation!. Anyway, US is under the same trend. Laboratory developed tests were initially regulated 25 years ago and there are still pending issues in the new draft legislation. If you want to know the details, an article in Clinical Chemistry explains the whole issue.

A quarter of a century after the FDA first asserted regulatory authority over LDTs in a draft guidance document, rules and/or guidance regarding LDT oversight have not been implemented. As such, legal questions regarding MDA authority over LDTs and the FDA draft guidance approach have neither been escalated to nor resolved by the judiciary. In addition, many questions central to this debate have not been answered. Are clinical laboratories manufacturers? Should laboratory devices and procedures be regulated similarly? Are there always clear limits between laboratory operations and the practice of laboratory medicine? Any future LDTregulatory or legislative efforts will need to balance and address these concerns if they are to be successful. It is unlikely that interpretation of current statutes and regulations can fully resolve these issues.

 Josep Moscardó, Barcelona landscape

Tuesday, January 2, 2018

The cost of a year of life gained

Four years ago in my post: How much does healthcare cost during your life? I said  that it was 111.936 € for women and 81.566 € for men (on average and without any additional assumption about changes in unit costs or quality of life). Now you can find in Health Economics, an estimation of the cost of one additional year of life adjusted by quality.
 The mean cost of an additional Quality-Adjusted Life Year (QALY) within a National Health Service (NHS) reveals how much health is lost, on average, when services currently provided by the NHS are displaced. This value has been suggested as a proxy of the average opportunity cost required to set a cost-effectiveness threshold when facing fixed budget constraints. The aim of this paper is to generate information on the marginal cost per QALY in the Spanish NHS that can be used to inform a cost-effectiveness threshold
And the answer is:
A cost per QALY of between 21,000€ and 24,000€ in Spain, depending on whether we take an average across different age groups or the value derived from the whole population model, respectively.

Conclusion: A cost-effectiveness threshold based on the estimated opportunity cost derived from this study is below the figure of 30,000€ commonly cited in Spain. Further work on societal values of health gains is needed to provide decision makers with the relevant information required in different decision-making contexts.
Interesting result, though expenditures are not necessary "social preferences". Cost-effectiveness threshold literature sometimes try to focus on a normative decision for the society society from a technical point of view. I'm interested in the political one.

Au Grand Palais, maintenant

Monday, January 1, 2018

Evidence of what

Evidence-Based Health Policy

Evidence as a topic suggests a common shared framework of values. We all know that this is far from current health policy across countries and within countries. Evidence is difficult to assess without taking into account the underlying values of a community. However, health economists and epidemiologists insist on it. In my opinion we have to know better what works according to social expectations. However we have to avoid the confusion between any descriptive and normative framework. Evidence sounds that any desparture from it may sound unacceptable.
Anyway, NEJM provides a perspective on the issue, and these are key statements in a figure:

Sunday, December 31, 2017

The constraints to genomic editing

CRISPR… ¿debemos poner límites a la edición genética?

A new publication by Fundació Grifols highlights the potential constraints to genomic editing. It is a good moment to have a look at it. Savador Macip says:
Los peligros, pues, son muchos, tantos como las cosas buenas que la edición genética nos puede aportar. De alguna forma, recuerda la energía nuclear. Descubrir los secretos del átomo nos ha permitido acceder a una cantidad inimaginable de energía, que usamos diariamente, pero que se debe regular de una forma muy precisa para evitar accidentes terribles y contaminaciones no deseadas. Y, lo que es más peligroso aún, la misma información sirve para fabricar una de las armas más mortíferas que conocemos, capaz incluso de destruir el planeta. A otra escala, CRISPR/Cas9 podría tener efectos parecidos.

La ciencia no se detiene, siempre continúa avanzando, y la sociedad corre el peligro de quedarse atrás. Por ello es importante que los debates sobre hacia dónde queremos ir empiecen cuanto antes mejor y que en ellos participe una muestra amplia de la población, no solo los científicos. Para conseguirlo es necesario que el máximo número posible de gente esté bien informada acerca de los avances más recientes, que entienda su alcance y sus implicaciones y que haga el esfuerzo de contribuir en los debates. A la vez, los científicos deben salir a explicar qué está pasando en sus laboratorios y los políticos deben proporcionar plataformas necesarias para estas discusiones. Solo así nos aseguraremos de que estos descubrimientos son usados
A must read.

Side effects, a good film to watch

Sunday, December 24, 2017

Diagnostic testing and outcomes

When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine

There are five causes of testing-related diagnostic error:
  • An inappropriate test is ordered
  • An appropriate test is not ordered
  • An appropriate test result is misapplied
  • An appropriate test is ordered, but a delay occurs somewhere in the total testing process
  • The result of an appropriately ordered test is inaccurate
If we know that that these are the causes, are there any measures available?
In Lundberg’s model, the value of laboratory results is influenced by events
that occur before the sample reaches the laboratory and after the results are released
from it. His model encompasses the physician’s cognitive involvement at the start of
the process and at the end.