Friday, January 18, 2019

Return of the Anechoic Effect - Rest in Peace, Health Wonk Review

Introduction: Blogging About Taboo Topics in Health Care

We started Health Care Renewal in 2004 to discuss the causes of health care dysfunction that rarely were mentioned in polite conversation at the time.  When we started Health Care Renewal, such issues as suppression and manipulation of research, and health care professionals' conflicts of interests rarely appeared in the media or in medical and health care scholarly literature.  While these issues are now more often publicly discussed, many other topics, such as  deceptive marketing of health care products and services; distortion of health care regulation and policy making through propaganda and disinformation,  regulatory capture, and the revolving door; ill-informed. mission-hostile, conflicted  corrupt or criminal leadership; etc, etc, etc; still rarely appear in the media or scholarly literature, and certainly seem to appear much less frequently than their importance would warrant (see this post).  For example, a survey by Transparency International showed that 43% of US resondents thought that American health care is corrupt.  It was covered by this blog, but not by any major US media outlet or medical or health care journal.  We have termed the failure of such issues to create any echoes of public discussion the anechoic effect.

Public discussion of the issues above might discomfit those who personally profit from the status quo in health care.  As we noted above, the people who profit the most, those involved in the leadership and governance of health care organizations and their cronies, also have considerable power to damp down any public discussion that might cause them displeasure. In particular, we have seen how those who attempt to blow the whistle on what really causes health care dysfunction may be persecuted.  But, if we cannot even discuss what is really wrong with health care, how are we going to fix it?

In the early 2000s, new internet based platforms appeared that allowed us and others to publish facts and opinions about health care dysfunction that otherwise were taboo.

The Darkness Gathers

Unfortunately, now the world of incisive medical and health care policy discussion is contracting again. Health Wonk Review, a compendium of the best blogging in health care policy, is closing down.  The email from its founders and blog-meisters read:

After a baker’s dozen years  and more than 280 issues, we’ve decided to call it a day.

It’s become a bit more of a heavy lift to get varied hosts.

We moved to a monthly issue to address that, but it’s still been slow going.

Submissions are down too as more people abandon blogs in favor of social channels like Twitter and LinkedIn.

Readership and cross posting appears to have waned, too. 

Going forward, we may host an ad hoc issue occasionally under the HWR banner and invite your participation when health policy issues rise to the surface, but the regular issues will cease.

So it joins the many medical and health care blogs I used to follow to help learn about what was really going on in health care, including items that it was considered impolite to discuss too loudly, lest they offend the powers that be. Some worthy blogs now gone are,  in alphabetical order:

1BoringOldMan - since 2017, after the death of its revered blogger, Dr Mickey Nardo

Carlat Psychiatry Blog - 2017, by Dr Daniel Carlat

HealthBeat - 2015, by journalist Maggie Mahar

HealthNewsReview - 2018, by journalist Gary Schwitzer

Hooked: Ethics, Medicine and Pharma - 2014, by Dr Howard Brody

Not Running a Hospital - 2016, by former hospital CEO Paul Levy

PharmaGossip - 2016, by an anonymous blogger

Scientific Misconduct Blog - 2010, by Dr Aubrey Blumsohn

Side Effects- by journalist Alison Bass

Note that the content of blogs with links above is still available, but the bloggers are not posting any more.

What Next?

Blogs, which were seen as a big innovation in the early 2000s, now of course seem a bit old fashioned and stuffy only a few years later.  However, blogs then served an important purpose.  They provided publication platforms which were immediate, and not subject to external editing, publication delays, or the worries of publishers' attorneys or corporate leaders.

Many of us went to blogging to discuss anechoic issues because it was so difficult to inject these discussions into the media, or medical or health care scholarly publications, at least without long delays, and editing that was not always helpful, and at times took not only the edge off, but much of the content as well. 

However, as the leaders of Health Wonk Review indicated above, social media is now all the rage. But social media has weaknesses, and social media platforms may not replace blogs.

Blogs can be as immediate as Twitter, for example (and I confess I do have a Twitter feed.)  But they allow longer form posts that can include nuance, complex arguments, analytic approaches, etc.  Anyone can read most blogs.  They do not push people to identify as followers.  They do not necessarily come with advertisements, with atttempts to profile readers for marketing purposes. They do not only supply thoughts selected for similarity with what one has read before, and hence can take a reader out of his or her algorithmically developed bubble.

However, I fear that in losing blogs such as these, we lose important voices that have helped challenge our pre-existing beliefs, illuminated what has gone wrong with health care, and showed us the way forward.

So rest in peace, Health Wonk Review.  I hope that there will be some way to continue the vigor of discussion that characterized it, and other health care blogs which are now defunct.
 



Tuesday, January 08, 2019

The Mysteries Surrounding Rhodes Pharmaceuticals, the Sackler Family's Second Opioid Company



 Mysteries still abound in the not so wonderful world of health care dysfunction, so, quick, the game's afoot...

Today's mysteries involve beneficial ownership.  Beneficial ownership questions are important to anti-corruption campaigners.  Beneficial ownership simply refers to "anyone who enjoys the benefits of ownership of a security or property, without being on the record as being the owner." (per Wikipedia). Concealing who really owns a company enables concealing sources of funds (as in money laundering), market power (when the owner also owns competitors), and sources of political influence, and enables those benefiting from the actions of the company to escape responsibility for their consequences.

A few months ago, a big question about the beneficial ownership of a local (to me) company suggested important local and national health care implications, and yet the case has remained anechoic.  The case has some mysterious aspects.

The  Mystery of the Ownership of Rhodes Technologies and Hence Rhodes Pharmaceuticals Solved

In September, the UK based Financial Times reported,

The billionaire Sackler family, which has been blamed for fuelling the US opioid addiction epidemic, owns a second drugmaker that churns out millions of addictive painkiller pills every year, the Financial Times can reveal.

The Sacklers are best known as the owners of Purdue Pharma, the privately held drugmaker that makes the now infamous opioid painkiller OxyContin, which has been described as 'heroin in a pill'.

However, an FT analysis of company registration documents has established that the family also owns Rhodes Pharma, a little-known Rhode Island-based drugmaker that is among the largest producers of off-patent generic opioids in the US.

Furthermore,

Rhodes Pharmaceuticals was set up in 2007, four months after Purdue pleaded guilty to federal criminal charges that it had mis-marketed OxyContin over the previous decade.

The little-known company now makes several opioid-based products containing highly-addictive drugs such as oxycodone, morphine and hydrocodone, according to a US Food and Drug Administration database. Many of its drugs are made in factories owned by Purdue.

The Mystery of the Mysteriousness of the Rhodes Companies and Facility

The FT report was noted by our local on-line news site, GoLocalProv, which tried to find out more about the company. It reported,

And tucked away in Coventry, Rhode Island, along a country road, is Rhodes Technology — surrounded by massive security. The company’s website has been under -reconstruction for the past few years -- all an effort to keep a low profile.

A 2005 version of the Rhodes Technologies’ website GoLocal uncovered said, 'We have very broad capabilities in developing sophisticated chemicals and offer confidential production of high purity APIs and finished dosage forms of innovative pharmaceuticals, as well as marketing and sales services. A multi-million dollar investment in a new cGMP facility completed in 2002 added controlled substances to our manufacturing capabilities. Rhodes is a diversified, dependable firm well positioned for partnerships.'

The marketing arm of the Rhodes Technologies is Rhodes Pharmaceuticals and it self-describes itself as 'a privately held company headquartered in picturesque Rhode Island....developing and distributing quality pharmaceutical products since 2008.'

Emails and requests for an interview were not responded to by Rhodes Pharmaceuticals.

GoLocalProv article included a blurry picture of a large factory building apparently copied from an old website.  I could find no pictures or descriptions of the Rhodes facility on the web other than the picture below from Google Satellite:




The satellite picture does suggest that the Rhodes facility is apparently massive.  However, I could find nothing, at least via web searching, to otherwise describe it.  Despite its size, I could find no coverage of the company, the facility, the buidling of the facility (which likely was quite a project), or anything else relevant in local media, or on the web.

The reasons to keep the ownership of this company mysterious are not hard to fathom.  But the reasons for the company itself to maintain such a "low profile," and for its facilities to be so well hidden, and to have such "massive security" (not otherwise described by GoLocalProv), are ongoing mysteries.

The Mystery of the Sackler Family's Opioid Market Power Partly Solved


It appears that the Sackler's previously secret ownership of Rhodes enabled them to conceal their market power. Per the FT,

Purdue Pharma has always insisted that its drug OxyContin cannot be considered a prime culprit in the crisis because it accounts for only 1.7 per cent of overall opioid prescriptions in the US.

However, Rhodes and Purdue combined accounted for 14.4m opioid prescriptions in 2016, according to figures seen by the FT, giving them a total share of 6 per cent of the US opioid market.

That puts the combined Rhodes-Purdue in seventh place among opioid makers by market share, behind Teva, the generic drugmaking giant, and well ahead of other pharma groups that have been named in lawsuits, such as Johnson & Johnson and Endo.

'This further debunks the Sackler family’s whole claim that they are not responsible for the crisis,' said Andrew Kolodny, a professor at Brandeis University who is one of the foremost experts on the US addiction epidemic.

He added: 'They have always said, ‘Why is everyone picking on us, we’re only 2 per cent of prescriptions?' A spokesperson for the family declined to comment.

A second GoLocalProv article also revealed that

The billionaire family whose company is being sued by states and cities across the country for their role in creating the opioid crisis is now launching a new recently patented antidote for the drug known as ‘heroine in a pill.’

Both oxycodone and the new drug will be produced side-by-side at the Rhodes Technologies plant -- an affiliate company of Purdue Pharma -- in Coventry, Rhode Island.

To corroborate that,

The U.S. Patent and Trademakr [sic] Office information shows the Rhodes Technologies’ plant in Coventry, RI is assigned the patent for the new drug. Rhodes Technologies is the subsidiary of Purdue Pharma owned by the Sackler family.

Calls and emails to Rhodes Technologies and its affiliated marketing company Rhodes Pharma have not been responded to.

Note that the "new drug" that is considered an "antidote" to oxycodone is simply a minor modification of an old drug, buprenorphine, already used to treat opioid addiction.  Per Stat News,

The patent concerns a new formulation of buprenorphine, one of the medications shown to help people with opioid addiction. It is already approved by the Food and Drug Administration in tablet and film form, but the patent describes a wafer that could dissolve even faster than existing forms when put under the tongue.

The patent says that the faster the treatment dissolves, the less risk there is for diversion.

So now we know more about the power of the Sackler family in the opioid market.

The Mystery of Accountability for Deceptive Marketing of Opioids Partly Solved

Purdue Pharma has a long and sorry history of deceptive marketing of its narcotics, and has been accused of being a major driver of the ongoing opioid (narcotic) epidemic.  The case has recently been very well covered in the media.  (Our latest discussion is here, our discussion of Purdue Pharma's first legal troubles, which were fairly anechoic at the time, is here, and all our Purdue Pharma related posts are here.)

It appears that the Sackler's concealed ownership of Rhodes Technologies/ Pharma also put them in a position to generate more financial conflicts of interest among physicians which could be used to enable more deceptive marketing.  A search of the ProPublica "Dollars for Docs" data base revealed that Rhodes paid $1.43M to physicians from August, 2013, to December, 2016.  They paid the most, $121K, to a single physician in Saint Charles, MO.

Admittedly, their contribution to physicians' conflicts of interest was modest compared to that of the Sackler's better known Purdue Pharma, $27.9M over the same time period, but it should not be overlooked.

So we now know a bit more about the extent Sackler family owned opioid manufacturers enlisted physicians to market their products, at times deceptively. 

The Mystery of the Sackler Family's Political Influence

This is admittedly speculation, but it is possible that Rhodes Technologies/ Pharma was also used as a vehicle for political influence to affect policy making relevant to the Sackler's interests.  Purdue Pharma certainly has a track record of such influence.

For example, we noted here that Purdue Pharma donated money to the Washington Legal Foundation in support of its efforts to weaken enforcement of laws that could have penalized the company's misbehavior.   In particular, the Washington Legal Foundation challenged the responsible corporate officer doctrine that allowed legal action against corporate executives for company wrong-doing that occurred on their watches.  Perhaps corporate leaders were worried that its executives could again face penalties, given the Purdue Pharma executives had previously pled guilty to misbranding Oxycontin (look here).  Purdue Pharma had also worked with the Washington Legal Foundation to push against guidelines from the Centers for Disease Control that would have potentially reduced opioid prescribing.

Furthermore, we noted here that Rudolf Giuliani, now President Donald Trump's lawyer, and previously and probably currently highly influential in the Trump regime, formerly represented Purdue Pharma and had helped mitigate the company's punishment for past mischief, an interesting example of the revolving door from the pharmaceutical industry to government.

So I think it is reasonable to say that whether Sackler-owned Rhodes Technologies/ Pharma was also used as a tool to conceal political influence remains a mystery.

Summary

So we now know that the Sackler Family, owner of Purdue Pharma, also owns a generic pharmaceutical company that manufacturers an important portion of the narcotics sold in the US.  Thus the share of the opioid market held by the Sackler family is likely four times larger than was previously apparent .  The Sackler's generic drug company is now known to have paid physicians a small but important amount to assist in its marketing of opioids.  It is also possible that the generic company also has been used to increase the family's influence over politics and policy that increased opioid sales and hence its responsibility for the opioid epidemic.  Thus, it is likely that the Sackler family's responsibility for the ongoing opioid epidemic is larger than was previously appreciated.

Why the Sackler's may have concealed their ownership of the company seems obvious.  Why the company and its physical plant were so secretive is not so clear.  

It is unknown whether the family owns similar companies that have not been discovered.  It is unknown whether big pharmaceutical and other big health care corporations similarly have concealed beneficial ownership of other companies that could be used to conceal all manners of mischief.

Anti-corruption campaigner have pushed to reveal the beneficial ownership of all corporate entities.  (Look here for the relevant report from Transparency International.) They have made little headway, so far.  The case of the mysteries surrounding Rhodes Technologies/ Pharma should be another impetus to support this campaign. 

True health care reform requires all sorts of transparency, now particularly including transparency about corporate beneficial ownership.  

Wednesday, January 02, 2019

For the Years of Investigation to Come: a Guide to Resources for Challenging Health Care Corruption

The Enduring Problem of Health Care Corruption

Now arrives the years of investigation.  Here in the US, a new majority in the US House of Representatives promises multi-pronged investigations of, among other topics, the corruption that now seems pervasive at the highest reaches of the US government, corruption that has badly affected efforts to truly reform US health care (look here).  Meanwhile, similar investigations are likely to get underway in various US states.  We can only hope that this flurry of activity will end up with some positive steps to reduce US health care corruption, an enduring problem about which we often write.


As we wrote in August, 2017, Transparency International (TI) defines corruption as


Abuse of entrusted power for private gain

In 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.
the scale of corruption is vast in both rich and poor countries.

Also,
Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption in the richest parts of the world also has its costs.

The report got little attention.  Health care corruption has been nearly a taboo topic in the US, anechoic, presumably because its discussion would offend the people it makes rich and powerful. As suggested by the recent Transparency International report on corruption in the pharmaceutical industry,
However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Presumably the leaders of other kinds of corrupt organizations can do the same. 

When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects some other places, mainly  presumably benighted less developed countries.  At best, the corruption in developed countries that gets discussed is at low levels.  In the US, frequent examples are the "pill mills"  and various cheating of government and private insurance programs by practitioners and patients.  Lately these have gotten even more attention as they are decried as a cause of the narcotics (opioids) crisis (e.g., look here).  In contrast, the US government has been less inclined to address the activities of the leaders of the pharmaceutical companies who have pushed legal narcotics (e.g., see this post). 

However, Health Care Renewal has stressed "grand corruption," or the corruption of health care leaders.  We have noted the continuing impunity of top health care corporate managers.  Health care corporations have allegedly used kickbacks and fraud to enhance their revenue, but at best such corporations have been able to make legal settlements that result in fines that small relative to their  multi-billion revenues without admitting guilt.  Almost never are top corporate managers subject to any negative consequences.

We have been posting about this for years at Health Care Renewal, while seeing little progress on this issue.

Things only seem to be getting worse given the increasing evidence that the Trump administration is corrupt at the highest levels.   In January, 2018, we first raised the question about how health care corruption could be pursued under a corrupt regime.  We noted sources that summarized Trump's. the Trump family's, and the Trump administration's corruption..  These included a website, entitled "Tracking Trump's Conflicts of Interest" published by the Sunlight Foundation, and two articles published in the Washington Monthly in January, 2018. "Commander-in-Thief," categorized Mr Trump's conflicted and corrupt behavior.  A Year in Trump Corruption," was a catalog of the most salient cases in these categories in 2017.

In July, 2018, we addressed the Trump regime's corruption again  By then, more summaries of Trump et al corruption had appeared.   In April, 2018, New York Magazine published "501 Days in Swampland," a time-line of  starting just after the 2016 presidential election. In June, 2018, ProPublica reviewed questionable spending amounting to $16.1 million since the beginning of Trump's candidacy for president at Trump properties by the US government, and by Trump's campaign, and by state and local governments. Meanwhile, Public Citizen released a report on money spent at Trump's hospitality properties.  Meanwhile, the voluminous Tracking Corruption and Conflicts of Interest in the Trump Administration summary appearing in the Global Anti-Corruption Blog has grown and grown. 

 So the driver of US health care corruption may now be the executive branch of government and its relationship with the Trump family and cronies, trumping even the influence of health care corporate corruption.  

However, in our work we have been heartened to find some useful resources (although unfortunately none specifically targeted at health care corruption in the US).  To inspire others to join the fight against health care corruption and related ills, I take this opportunity to post an idiosyncratic list of some of the most helpful resources I have found (including one very new one).  In alphabetical order:



Basel Institute on Governance

Located in Basel, Switzerland,

an independent not-for-profit competence centre working around the world with the public and private sectors to counter corruption and other financial crimes and to improve the quality of governance.

The Institute does not have a specific health care focus, but focuses on broad issues with applicability to health care: asset recovery, public governance, corporate governance and compliance, collective action, and public finance management.

Curbing Corruption

This is a new website staffed by anti-corruption experts mainly based in the UK, meant

to appeal widely to people who want to take action to reduce corruption within their sector of society, and/or within their organisation. This includes Members of Parliament, the private sector, civil society organisations, professional associations, the media and the judiciary.

However, their main focus now are politicians and public officials.

The website includes sector specific resources, including a very extensive review document on the health sector.

Global Anti-Corruption Blog

A multi-author US based blog

devoted to promoting analysis and discussion of the problem of corruption around the world. This blog is intended to provide a forum for exchanging information and ideas across disciplinary and professional boundaries, and to foster rigorous, vigorous, and constructive debate about corruption’s causes, consequences, and potential remedies.

It includes an extensive list of international anti-corruption resources (much bigger than this idiosyncratic list), but which tellingly has no organization specifically focused on health care, and no organization specifically focused on US corruption.

Transparency International

Perhaps the best known international anti-corruption NGO (non-governmental organization), based in Berlin, Germany.  It proclaims 
 
From villages in rural India to the corridors of power in Brussels, Transparency International gives voice to the victims and witnesses of corruption. We work together with governments, businesses and citizens to stop the abuse of power, bribery and secret deals.

As a global movement with one vision, we want a world free of corruption. Through chapters in more than 100 countries and an international secretariat in Berlin, we are leading the fight against corruption to turn this vision into reality.

Its website is extensive.  It hosts more or less biannual International Anti-Corruption Conferences.  It provides many resources, including a well known annual international survey of corruption perceptions.  It has chapters in multiple countries (although, tellingly, its US chapter was dis-accredited in 2017, look here).

The TI UK chapter has a specific health care initiative focusing on the pharmaceutical industry.

U4 Anti-Corruption Resource Centre

Located in Bergen, Norway,

 U4 is a permanent centre at the Chr. Michelsen Institute (CMI) in Norway. CMI is a non-profit, multi-disciplinary research institute with social scientists specialising in development studies.

Its introductory statement

At U4, we work to reduce the harmful impact of corruption on society. We share research and evidence to help international development actors get sustainable results.

U4 provides publications and resources for various sectors, including health care.

Summary

Corruption in health care is a daunting problem, but 2018 showed us in the US that when people get upset enough about problems, things happen (albeit, not always great things).  So we urge all concerned about health care corruption to make things happen.  The resources above may help them do so.