Attempts to Transform the CDC into a Propaganda Outlet and the Silence of the Health Care Leaders

First they came for the CDC staffers, but I was not a CDC staffer so I did nothing...

Then they came for me. And there was no one left to speak for me.

- with apologies to Martin Niemoller (look here) 

The US is continuing to suffer during the coronavirus pandemic.  Meanwhile, the lead US government public health agency, the Centers for Disease Control and Prevention (CDC) has suffered two attempts by the Trump administration to transform it into a propaganda outlet.

Mysterious Revisions of Pandemic Management Guidelines to Hinder Testing of Exposed Persons

This story broke in late August, 2020.  As reported by the New York Times on August 25, 2020:

The Centers for Disease Control and Prevention quietly modified its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus.

The new guidelines went against public health practice for managing epidemics.  People who have been exposed are at increased risk of infection.  Infected people may not have symptoms but may still transmit the virus to others.  Identifying infected people allows them to be quarantined, and any further contacts to be traced.  In particular, as the NYT article pointed out:

Although researchers remain unsure how often asymptomatic people unwittingly transmit the coronavirus, studies have shown that the silently infected can carry the virus in high amounts. The evidence is more clear-cut for pre-symptomatic people, in whom virus levels tend to peak just before illness sets in — a period when these individuals might be mingling with their peers, seeding superspreader events. Notably, experts can’t distinguish asymptomatic people from those who are pre-symptomatic until symptoms do or don’t appear.

No Obvious Justification and No One Accountable for the Change

The CDC did not initially provide a clear justification of the change:

The reasons behind the surprise shift in testing recommendations are unclear. In response to an inquiry from The New York Times, a representative for the C.D.C. directed the questions to the U.S. Department of Health and Human Services. 

A report from ABC News on August 26 quoted Admiral Brett Giroir of the White House coronavirus task force:

This is evidence-based decisions that are driven by the scientists and physicians, both within the CDC, within my office in the lab task force, and certainly amongst the task force members

However, he did not provide any of the evidence on which it was supposedly based, or any logic underlying the change based on this evidence.  Nor did he make clear who was accountable for the change

 I worked on them. Dr. Fauci worked on them. Dr. Birx worked on them. Dr. Hahn worked on them. Dr. Atlas provided input. So, it's kind of hard to know how much was written by one person at this time

On the other hand, a CNN report from the next day suggested that the change came due to political pressure:

A sudden change in federal guidelines on coronavirus testing came this week as a result of pressure from the upper ranks of the Trump administration, a federal health official close to the process tells CNN, and a key White House coronavirus task force member was not part of the meeting when the new guidelines were discussed.

'It's coming from the top down,' the official said of the new directive from the Centers for Disease Control and Prevention.

 

An AP article from August 26 included speculation about the real reasons for the change:

 

Dr. Carlos del Rio, an infectious diseases specialist at Emory University, suggested in a tweet that there are two possible explanations.

One is that it may be driven by testing supply issues that in many parts of the country have caused widely reported delays in results of a week or more, he suggested.

 Admitting problems providing testing might be a reason to consciously temporarily limit testing, of course, but not to pretend the testing would not be useful.  Then

Another possible explanation for the change is that President Donald Trump simply wants to see case counts drop, and discouraging more people from getting tested is one way to do it, del Rio said in his tweet.

A Washington Post article on August 27, 2020 explained this further:

The revised guidelines come as President Trump has feuded with the CDC and the Food and Drug Administration, both parts of the Department of Health and Human Services, and marginalized officials who would ordinarily play leading roles in a pandemic response. He has repeatedly said that he did not like that more testing had revealed more cases.

'I said to my people, ‘Slow the testing down, please!’ ' Trump said at a rally two months ago. Aides said he had been speaking tongue-in-cheek. But asked later whether he had been kidding, Trump replied, 'I don’t kid.'

Reducing testing, of course, would reduce the number of apparent, not real cases, allowing Trump to exaggerate his ability to manage the pandemic

On September 17, 2020, the source of the controversial change in the CDC guideline was somewhat clarified again according to the New York Times:

A heavily criticized recommendation from the Centers for Disease Control and Prevention last month about who should be tested for the coronavirus was not written by C.D.C. scientists and was posted to the agency’s website despite their serious objections

The source of the change was 

the Department of Health and Human Services [which] did the rewriting and then 'dropped' it into the C.D.C.’s public website, flouting the agency’s strict scientific review process.

'That was a doc that came from the top down, from the H.H.S. and the task force,' said a federal official with knowledge of the matter, referring to the White House task force on the coronavirus.

Yet neither that nor earlier reports explained who at "the top" directed the change.

And soon the change it self disappeared as mysteriously as it appeared.  On September 18, 2020 per the AP:

U.S. health officials on Friday dropped a controversial piece of coronavirus guidance and said anyone who has been in close contact with an infected person should get tested.The Centers for Disease Control and Prevention essentially returned to its previous testing guidance

Criticism of the Change

 Public health and health care professionals criticized the changes, e.g.,  per the AP article of August 26, 2020:

Dr. Tom Frieden, who was head of the CDC during the Obama administration, said the move follows another recent change: to no longer recommend quarantine for travelers coming from areas where infections are more common.

'Both changes are highly problematic' and need to be better explained, said Frieden, who now is president of Resolve to Save Lives, a nonprofit program that works to prevent epidemics.

Also, Dr Leana Wen wrote an op-ed for the Washington Post on August 26, 2020:

you don’t have to be a public health expert to know the CDC’s guidance is nonsensical.  

In MedPage Today of August 28, 2020:

pulmonologist William Janssen, MD, section head of Critical Care Medicine at National Jewish Health, said the new guidance recommending testing for fewer people 'flies in the face of everything we have been told and understand about this disease.'

Also,

Another pulmonologist at National Jewish Health, Kenneth Lyn-Kew, MD, called the CDC move 'a step backwards.'

'The CDC was flat out wrong and the epidemiologists there know this,' he said, adding that testing and tracing are cornerstones of epidemiology.

Major health care organizations also criticized the change. The AMA issued a statement:

Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus. When the Centers for Disease Control and Prevention (CDC) updates a guidance the agency should provide a rationale for the change. We urge CDC and the Department of Health and Human Services to release the scientific justification for this change in testing guidelines

The American Association of Medical Colleges asserted:

These CDC guidelines go against the best interests of the American people and are a step backward in fighting the pandemic. The AAMC urges the CDC to return to its earlier testing recommendations

The Chair of the Board of Regents of the American College of Physicians wrote that the organization:

supports the use of science, based on the best available evidence, in the fight against COVID-19. Public health agencies should not be subjected to pressure or be influenced to issue policies that are not based on evidence and expert recommendations of their own scientists.

 Also

The recent revision of the CDC’s COVID-19 testing guidelines of asymptomatic individuals lacks transparency and clarity, sending a confusing message to both physicians and the public on appropriate and necessary testing that will ultimately help to mitigate the spread of COVID-19.

Summary

So far we only know that someone at "the top" of the government directed the change in the CDC guidelines.  No person or group has stepped forward as accountable. No one at any US government agency has explained the rationale for the change, much less provided clear evidence and logical reasoning underlying it.  The best explanation for the change seems to be that it fit President Trump's message. It would have made his administration's problems organizing adequate testing for coronavirus less apparent.  By reducing testing, it would make the rate of the spread of disease temporarily appear lower, allowing Trump to exaggerate his ability to manage the pandemic.

Yet I could find no health care or public health professional, or any leader of a health care organization willing to criticize "the top" of the US government for directing the change, to criticize the opaque, apparently evidence-free process that produced the change, or to question whether the change was meant to fit with Trump's propaganda, that is, his claims of brilliant management of the pandemic. 

Trump Political Appointees Attempt to Intimidate CDC Staff to Manipulate Publications in the Morbidity and Mortality Weekly

White House Installed Pro-Trump Propagandist with No Health Care or Public Health Background as Head of Public Relations for DHHS

 The second case began in April, 2020.  Then Politico reported:

 The White House is installing Trump campaign veteran Michael Caputo in the health department’s top communications position

Caputo was given the title of Assistant Secretary for Public Affairs. He has an unlikely background to have been named head of public relations for the Department of Health and Human Services (DHHS). He has no apparent background in health care or public health. Also, Politico noted:

Caputo is an intense Trump loyalist whose recent book 'The Ukraine Hoax,' alleged a conspiracy behind Trump’s impeachment.

Furthermore

 Caputo is a longtime friend of Trump ally Roger Stone and former Trump campaign chairman Paul Manafort, both of whom were convicted of crimes in the last two years. 

Then CNN reported:

The new spokesman for the Department of Health and Human Services in a series of now-deleted tweets made racist and derogatory comments about Chinese people, said Democrats wanted the coronavirus to kill millions of people and accused the media of intentionally creating panic around the pandemic to hurt President Donald Trump.

In particular,

In a series of tweets on March 12, Caputo responded to a baseless conspiracy theory that the United States brought the coronavirus to Wuhan, China, by tweeting that 'millions of Chinese suck the blood out of rabid bats as an appetizer and eat the ass out of anteaters.'

 

CNN had many more graphic examples.  

 

Also, Mother Jones reported more about Caputo's involvement in Russia and Ukraine:

 

A longtime Republican operative who was ousted from a job on Trump’s 2016 campaign, Caputo recently worked to boost discredited claims alleging that Ukraine, not Russia, meddled in the 2016 election.

 

In particular, Caputo was alleged to have been involved in political dirty tricks on behalf of Trump in 2016:

 

In June 2018, the Washington Post reported that ... [Caputo] and Stone had met in 2016 with Henry Oknyansky, a Russian expat living in Florida, who wanted to sell damaging information about Hillary Clinton. Caputo, in text messages with Stone the Post obtained, referred to Oknyansky as 'the Russian.' Though no deal was reached, news of the meeting seemed to contradict claims both Stone and Caputo had made in testimony to the House Intelligence Committee. Both men denied any contact with Russians during the 2016 campaign.

 

Also, Caputo was alleged to have been involved in creating propaganda or disinformation about Ukraine's supposed intervention in the 2016 campaign, and Hunter Biden's actions there:

 

Last year, Caputo, along with other figures in Trump’s orbit, turned his focus to Ukraine. He says he travelled there last August to try to bolster the theory that Ukrainians interfered in 2016 election to help Clinton. He subsequently wrote a book, titled The Ukraine Hoax: How Decades of Corruption in the Former Soviet Republic Led to Trump’s Phony Impeachment, which pushes discredited allegations, including claims that former Vice President Joe Biden intervened in Ukrainian affairs to help his son, Hunter. Caputo produced a documentary offering similar allegations that aired in January on the rabidly pro-Trump One America News. Giuliani starred in a separate OAN series which pushed similar claims based his own trip to Ukraine.

 

Yet  despite Caputo's record as an unscrupulous political operator, and allegations that he was involved in peddling propaganda and disinformation, his appointment drew no outcry.

Assistant Secretary for Public Relations of DHHS Orchestrated Intimidation to Distort the Morbidity and Mortality Weekly Report

Somehow Caputo and the associates he brought to the DHHS managed to avoid much public notoriety for a few months.  Then on September 11, 2020 Politico reported that Caputo and his associates had been quietly busy.  Their apparent mission was to turn the respected CDC public health publication, the Morbidity and Mortality Weekly Report, into a vehicle for pro-Trump propaganda.  Politico noted that:

The CDC's Morbidity and Mortality Weekly Reports are authored by career scientists and serve as the main vehicle for the agency to inform doctors, researchers and the general public about how Covid-19 is spreading and who is at risk. Such reports have historically been published with little fanfare and no political interference, said several longtime health department officials, and have been viewed as a cornerstone of the nation's public health work for decades.

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department's new spokesperson, there have been substantial efforts to align the reports with Trump's statements, including the president's claims that fears about the outbreak are overstated, or stop the reports altogether.

In particular, Caputo et al tried to

retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior

and

halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence

To underscore that the effort was to promote Trump's political self-interest

an aide to Caputo berated CDC scientists for attempting to use the reports to 'hurt the President' in an Aug. 8 email sent to CDC Director Robert Redfield and other officials that was widely circulated inside the department and obtained by POLITICO. 'CDC to me appears to be writing hit pieces on the administration,' appointee Paul Alexander wrote, calling on Redfield to modify two already published reports

Alexander tried to gain control of the contents of the MMWR, calling

 on Redfield to halt all future MMWR reports until the agency modified its years-old publication process so he could personally review the entire report prior to publication, rather than a brief synopsis. Alexander, an assistant professor of health research at McMaster University near Toronto whom Caputo recruited this spring to be his scientific adviser, added that CDC needed to allow him to make line edits — and demanded an 'immediate stop' to the reports in the meantime.

Apparently CDC staffers resisted Caputo, Alexander et al, so that eventually contents untouched by their manipulations did become public.

One day after the Politico article, the New York Times  confirmed its essential findings

Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies said on Saturday that meddling from Washington was turning widely followed and otherwise apolitical guidance on infectious disease, the Morbidity and Mortality Weekly Reports, into a political loyalty test, with career scientists framed as adversaries of the administration.

The Times called Caputo's work a "bullying operation."  

The Washington Post also confirmed the Politico report after gaining access to emails sent by Alexander.

The Assistant Secretary's Actions Became Bizarre, and He Resigns Citing Mental Health Issues

As soon as the story of his attempts to "bully" the MMWR became public, Caputo's actions became more bizarre.  On September 14, 2020, the New York Times reported:

The top communications official at the powerful cabinet department in charge of combating the coronavirus made outlandish and false accusations on Sunday that career government scientists were engaging in 'sedition' in their handling of the pandemic and that left-wing hit squads were preparing for armed insurrection after the election.

Michael R. Caputo, the assistant secretary of public affairs at the Department of Health and Human Services, accused the Centers for Disease Control and Prevention of harboring a 'resistance unit' determined to undermine President Trump, even if that opposition bolsters the Covid-19 death toll.

Then he announced:

he personally could be in danger from opponents of the administration. 'If you carry guns, buy ammunition, ladies and gentlemen, because it’s going to be hard to get,' he urged his followers.

He went further, saying his physical health was in question, and his 'mental health has definitely failed.'

'I don’t like being alone in Washington,' Mr. Caputo said, describing 'shadows on the ceiling in my apartment, there alone, shadows are so long.'

 One day later Politico reported an announcement:

Today, the Department of Health and Human Services is announcing that HHS Assistant Secretary for Public Affairs Michael Caputo has decided to take a leave of absence to focus on his health and the well-being of his family

Alexander also left the agency 

Since Caputo's departure, Politico published an article detailing how he placed "his own loyalists and Trump veterans" into public relations positions at the DHHS. 

Also, the New York Times published an article detailing some of his efforts to bully CDC staff,

Mr. Caputo moved to punish the C.D.C.’s communications team for granting interviews to NPR and trying to help a CNN reporter reach him about a public relations campaign. Current and former C.D.C. officials called it a five-month campaign of bullying and intimidation.

For instance, after Mr. Caputo forwarded the critique of Dr. Schuchat to Dr. Redfield, C.D.C. officials became concerned when a member of the health department’s White House liaison office — Catherine Granito — called the agency to ask questions about Dr. Schuchat’s biography, leaving the impression that some in Washington could have been searching for ways to fire her.

In another instance, Mr. Caputo wrote to C.D.C. communications officials on July 15 to demand they turn over the name of the press officer who approved a series of interviews between NPR and a longtime C.D.C. epidemiologist, after the department in Washington had moved to take ownership of the agency’s pandemic data collection.

'I need to know who did it,' Mr. Caputo wrote. A day later, still without a reply, Mr. Caputo wrote back. 'I have not received a response to my email for 20 hours. This is unacceptable,' he said.

Efforts to Turn the MMWR Into Propaganda Criticized byAcademics in Public Health and Health Care, and the CEO of the Robert Wood Johnson Foundation

Per the Politico article above, Jennifer Kates, leader of the Kaiser Family Foundation's global health work

defended the CDC's process as rigorous and said that there was no reason for politically appointed officials to review the work of scientists.

Per the New York Times article above, Dr. William Schaffner, an infectious disease specialist at Vanderbilt University who sits on the external editorial board of the Morbidity and Mortality Weekly Report, said Caputo's operation 

undermines the credibility of not only the M.M.W.R. but of the C.D.C. And the C.D.C.’s credibility has been tarnished throughout Covid already

Per USA Today on September 13, 2020:

The interference is not just anti-science but disinformation intended to deceive the American public, said Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.

'This is outright egregious. It’s despicable,' Topol said, accusing Redfield and other leaders of allowing the agency to be hijacked by politics.

Also,

 On Twitter, Dr. Sherri Bucher, a global health researcher, wrote, 'There are no words to articulate how horrific this is. Trust & credibility, shattered, overnight. MMWR has been, for a long time, one of the most reliable, steadfast, scientific resources; unquestioned veracity, impeccable reputation for quality of data/analysis. No longer.

The Washington Post published an op-ed by Dr Erin Marcus, a professor of clinical medicine at the University of Miami Miller Medical School:

Caputo’s manipulation is appalling. If left unchecked, it could have disastrous consequences for the reputation and reliability of the CDC, which has already been battered by the U.S. response to covid-19. It could also prove devastating for medical practice in the United States more broadly.

In Scientific American, Dr Richard Besser, the CEO of the Robert Wood Johnson Foundation, wrote an op-ed entitled "We can't allow the CDC to be tainted by politics," noting:

 To meddle with, delay or politicize these [MMWR] reports would be a form of scientific blasphemy as well as a breach of public trust that could undermine the nation’s efforts to fight the coronavirus.

Summary

So to summarize, the White House put a pro-Trump political operative who had allegedly been involved in producing propaganda and disinformation in support of Trump to oversee all Department of Health and Human Services communications.  He and his hired cronies tried to bully and intimidate DHHS, particularly CDC staff, and to distort the contents of the renowned MMWR to support the Trump message.  Had these efforts succeeded they would have seriously impeded efforts to control the coronavirus pandemic by undermining the dissemination of scientific evidence needed for pandemic management and clinical care for affected patients.  

I found several academic public health and health care professionals willing to criticize Caputo and cronies' actions.  I found one leader of a prominent health care foundation willing to at least implicitly criticize them.  I found no one willing to hold accountable anyone at the "top" of the government who hired Caputo or encouraged his actions.  On this case, I could find no leader of a health care organization other than Dr Besser willing to say anything at all.   

Conclusions

Last month, we noted how disinformation about the coronavirus pandemic is being disseminated by the US president. 

Since then, two major efforts to use the CDC, the lead US public health organization, to support President Trump's political messaging, in effect, to function as a political propaganda outlet.  Individual US academic and practicing public health and health care professionals have been willing to decry these efforts, though not to directly hold Trump and his top lieutenants in the executive branch accountable.  In some cases, leaders of major medical organizations have been willing to state the principles that should have been upheld within the government.  

However, no chairpersons, deans, chancellors, vice-presidents for health affairs, university presidents; or journal editors, hospital executives, leaders of professional societies, executives of health care corporations, etc, etc were willing to publicly challenge Trump and his top collaborators.  Such leaders so far have also been unwilling to challenge Trump's efforts to spread disinformation.

To be charitable, such leaders may be to used to a kinder, gentler era to be able to fully comprehend that parts of the US government meant to be apolitical advocates for public welfare, such as the CDC, are being pushed to become part of an incipient Ministry of Propaganda.  

Fighting a deadly pandemic is hard enough.  It is gut wrenching that the fight is being subverted by political leaders spreading propaganda and disinformation.  It is sad that front line public health and health care professionals are hardly supported in their work by those who claim to lead them.  Where is the courage?  Where is the outrage?

"If not now, when?"

 

Making Research Suppressed Again - US Secretary of Health Candidate Accused of Suppressing Clinical Research at Behest of Campaign Donor

Introduction - Research Suppression

An early impetus for us to start Health Care Renewal in 2004 was our perception that the integrity of clinical research was under threat.  In particular, we noted increasing number of cases in which  commercial marketing concerns seemed to result in the manipulation of clinical research to enhance the apparent attractiveness of specific products, usually drugs or devices.  When such manipulation failed to make products look good, research could be simply suppressed. 

My personal introduction to health care dysfunction was the case of my own supervisor and friend, Dr David G Kern, who ultimately lost his academic position because he refused to go along with the suppression of research he had done on a new occupational disease, research that offended the company at whose site the disease occurred (look here).

Per the tenets of evidence-based medicine, health care professionals and patients should rely on the results of the best clinical research, sceptically appraised, to make clinical decisions.  Suppressed or manipulated research could lead to bad decisions, hence patients failing to get the best tests and treatments, or getting unncessary or dangerous tests and treatments, and ultimately harming patients.

Since then, research manipulation and particularly suppression have become well known issues.  For example, the international AllTrials campaign aims to prevent suppression of randomized controlled trials.  Since these issues are now widely discussed, Health Care Renewal has not posted so much about them recently.

But suddenly it apprears that research suppression is again a national issue for the US.  Dr Tom Price,  just nominated by the Trump administration to be the US Secretary of Health and Human Services, the highest government health policy position, has been accused of involvement in an effort to suppress dissemination of clinical research at the behest of a campaign donor.  

Background - Bildil

Back in 2005, we posted about the strange story of the promotion of Bildil.  Briefly, Bildil is a fixed combination of two very old vasodilator anti-hypertensive drugs, hydralazine and disosorbide dinitrate.  Back in the 1980s, these two drugs were shown to prolong life for patients with congestive heart failure (CHF) and systolic dysfunction.  In 1991, another class of drugs, angiotensin converting enzyme (ACE) inhibitors (or ACEIs) were shown to better prolong life than hydralazine - isosorbide dinitrate.

In 2004, a company called Nitromed sponsored a trial of Bildil.(1)  It recruited only patients who self-identified as "black," and showed that the fixed combination of the two old drugs was superior to placebo in prolonging survival for patients already taking the current conventional therapy for heart failure (that now usually includes an ACE inhibitor or an angiotensin receptor blocker [ARB]).

There were some issues with that trial, as we noted in 2005, NitroMed got the US Food and Drug Administration (FDA) to approve a trial limited to only a single racial/ethnic group, but the US National Institutes of Health (NIH) has for years required clinical trials to include a broad selection of under-represented minorities (i.e., groups other than African-Americans), and prohibited exclusion of such groups unless there is a clear reason to do so. (See the policy here.) If NitroMed had included patients who were diverse in terms of race/ ethnicity, it might have been possible to see if hydralazine - isosorbide dinitrate actually works differently in patients with differing race/ ethnicities. But allowing only "black" patients in the trial prevented drawing any conclusions about whether the drug would work better, similarly, or not as well in, for example, Asian-Americans, Latinos, American Indians, and whites. 

Dr Tom Price, Arbor Pharmaceuticals, and the Attempted Supression of Dissemination of Clinical Research

Since then, Bildil has not sold well.  As ProPublica reported

The $3 pill [now] known as BiDil was already a difficult sell when a Georgia-based pharmaceutical company bought the marketing rights a few years ago. A treatment for African Americans suffering from heart failure, BiDil had never really caught on, forcing the drug company that developed it to take a buyout offer.

The issue was a study done in 2009.

The study led by Karl Hammermeister, a cardiology professor at the University of Colorado School of Medicine, and originally published in the journal Clinical Therapeutics in 2009, found that BilDil was not actually associated with a significant reduction in death or 2009 hospitalization.(2) The study found that in all but one of its test groups the drug was associated with significantly increased risk of hospitalization for heart failure.

The drug's new manufacturers had new ideas about marketing it.

So last summer, the new owner of the drug, Arbor Pharmaceuticals LLC of Atlanta, sought to get the study taken down from a government website. For help, the company turned to the office of a congressman to whom the CEO had given the maximum $2,700 campaign donation — Rep. Tom Price, the Georgia Republican nominated by Donald Trump to become head of the Department of Health and Human Services.

Over the next few months, one of Price’s aides emailed the federal Agency for Healthcare Research and Quality at least half a dozen times, asking at one point 'what seems to be the hold up' in getting the [2009 Hammermeister] study removed from the website, which aims to help patients, health care providers and policy makers make 'better treatment choices.' In the end, the agency, which is part of the Department of Health and Human Services, kept the study online but added a note: 'This report is greater than 5 years old. Findings may be used for research purposes but should not be considered current.'

In particular,

Gary Beck, a policy assistant to the congressman, first reached out to the federal research agency about the study in July, emails show. 'I have been in contact with representatives from Arbor Pharmaceuticals based in Georgia in regard to some issues they have with the study that is linked below,' he wrote, adding that the company told him 'the study might be outdated' and they wanted it removed from the website.

'I wanted to get in touch with you to get a better grasp on the situation and what seems to be the hold up,' Price’s aide wrote.

Francis Chesley, an official at the agency, responded to Beck, saying he would check into the matter. Three days later, Beck followed up again. Chesley told him the agency was examining its website archiving policy to ensure the public had access to up-to-date information, and offered to talk to the pharmaceutical company directly.

Beck then pressed him: 'Is it in the opinion of the Center for Evidence and Practice Improvement,' he wrote, referring to the division doing the review, 'that the BiDil study could be determined as out-of-date once the examination is completed?'

Beck sent four more emails over the next four months. In November, seemingly exasperated by the fact that the study was still online, he asked: 'Would someone else at AHRQ be able to provide me with an update to this situation?'

There was a big problem with this.  While the 2009 study is no longer new, it cannot be considered outdated, because it has not been superseded by new evidence.

Since 2009, there seems to have been little original research done on hydralazine - isosorbide dinitrate for CHF.  A 2013 Cochrane Collaboration systematic review (3) concluded there was no clear evidence that this combination was superior to other drugs for CHF.  A study done using a clinical registry (not a randomized controlled trial) published in 2016 also showed no advantage from the combination, particularly for black patients.(4)

Furthermore, ProPublica quoted

Jonathan Kahn, a professor at the Mitchell Hamline School of Law in Minnesota who wrote a 2013 book about BiDil’s fraught history, has been a critic of marketing BiDil as a race-specific drug, arguing it was pitched as such for legal and commercial reasons, not to improve patient outcomes. He said he hasn’t independently assessed the 2009 study posted by the federal agency, but added in an email, 'there is NO WAY this study is outdated. It is much more recent than the studies underlying the approval of BiDil itself.'

Nonetheless, Arbor Pharmaceuticals persisted in its efforts to get Rep Price's office to suppress the AHRQ's dissemination of the apparently still relevant results of the 2009 study, and Dr Price appeared to gladly cooperate. 



Summary

Dr Tom Price, was once a practicing orthopedic surgeon, now is a US congressman with important health care policy responsibilities, and the current nominee to be US Secretary of Health and Services, the highest health care policy position in the US government.  Now there are credible allegations that Dr Price, as a congressman, aided a pharmaceutical company owned by a campaign donor in the company's attempt to suppress relevant information from clinical research on the company's product because that information questioned the product's usefulness.

We recently discussed some of Dr Price's other apparent conflicts of interest, involving his ownership of health care related stocks.  It appears that Dr Price had another conflict of interest, in that he was taking campaign money from a pharmaceutical company while he had responsibilities as a legislator in the health policy arena. 

ProPublica also noted, 

Last month, The Wall Street Journal reported that Price had traded more than $300,000 in shares in health-related companies as he played a role in legislation that could have affected their share prices.

Last week, Kaiser Health News reported that Price was given a “sweetheart” deal to invest in an Australian biotech company — a stake that has since showed a 400 percent gain. That company could benefit from the 21st Century Cures legislation Price supported. And this week, CNN reported that Price invested in Zimmer Biomet before introducing a bill that could have helped the medical device manufacturer. The company’s political action committee then donated $1,000 to Price’s campaign.

And now appears that Dr Price also had a role in trying to suppress dissemination of potentially useful clinical research based not on considerations of patient benefit, but based on commercial concerns of a pharmaceutical company.  Such research suppression could have led patients to get BiDil when better treatments are available, potentially denying them the best possible outcomes.

This suggests that Dr Price abused his entrusted power (to be part of a government of the people, by the people, and for the people) for private gain.  This appears to be corruption, at least in an ethical if not a legal sense, using the Transparency International definition (corruption is abuse of entrusted power for private gain).

Dr Price's conflicts of interest are disturbing.  His attempts to suppress dissemination of clinical research are more disturbing.  That he is now the nominee to be the Secretary of Health and Human Services is even more disturbing.

Our new US President famously declared his intention to "drain the swamp" in Washington DC.  What would be the point if he then plans to refill it, and stock it with new swamp dwellers?

References

1.  Taylor AL et al. Combindation of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med 2004; 351: 2049 -

2.  Hammermeister KE et al. Effectiveness of hydralazine/isosorbide dinitrate in racial/ethnic subgroups with heart failure. Clin Ther. 2009 Mar;31(3):632-43. doi: 10.1016/j.clinthera.2009.03.019. Link here.

3. Wakai A et al. Nitrates for acute heart failure syndromes. Cochrane Database Syst Rev. 2013 Aug 6;(8):CD005151. doi: 10.1002/14651858.CD005151.pub2. Link here.

4. Khazani P et al. Clinical Effectiveness of Hydralazine-Isosorbide Dinitrate Therapy in Patients With Heart Failure and Reduced Ejection Fraction: Findings From the Get With The Guidelines-Heart Failure Registry. Circ Heart Fail. 2016 Feb;9(2):e002444. doi: 10.1161/CIRCHEARTFAILURE.115.002444. Link here.

Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices

Health Care Corruption as a Taboo Topic

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 did not get much attention.  Since then, health care corruption has been nearly a taboo topic in the US.  When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries.  On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here).  But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries.  Health Care Renewal was practically the only source of coverage in the US of the survey's results.

Transparency International's New Report on Corruption in the Pharmaceutical Sector

Now Transparency International (TI) has tried, and Health Care Reenewal will try again.  In June, 2016 Transparency International published a new report entittled

Corruption in the Pharmaceutical Sector

The report's executive summary states:

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.

In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,

Manipulation of Clinical Research

We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients.  The TI report included: 

As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.

Suppression of Clinical Research

We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests.  The TI report included:

Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.

Manipulation of the Dissemination of Clinical Research

We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients.  For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:

The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.

Deceptive Marketing

We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm.  In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks.  The TI report included:

There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company’s medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.

Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors’ prescribing habits and encouraging off-label, unlicensed use to increase sales.

Other Topics

Finally, the report mentions such issues as the revolving door, regulatory capture, etc, etc, etc

A Striking, and Strikingly Anechoic Report

Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption.  That is a sentiment rarely heard in the US, and one that appears nearly taboo.  

Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries.  Let me note the important exceptions, however.

I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1)  The only substantial news article I could find on the report was also from the UK, in the Independent.  Its sub-title is worth repeating:

Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people

Also, there were brief articles in Reuters, and in (web-only) FiercePharma.  That is about it so far.

The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion.  Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure.  In the TI Report itself,

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.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks.  It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.


I might as well repeat myself once again.  As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it? 

So to repeat an ending to one of my previous posts on health care corruption....  if we really want to reform health care, in the little time we may have before our health care bubble bursts, we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations' misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is to be able to say or write the words, health care corruption.

Reference

1.  Torjesen I.  Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.

Pfizer's Latest International Pfiascos - Charges of Anti-Competitive Practices, Inflated Prices, Deception and Secrecy

Many big health care organizations seem to just be unable to keep out of trouble, and the bigger they are, the more kinds of trouble.  Pfizer Inc, considered to be one of the world's largest pharmaceutical companies, has supplied us with plenty of stories.  Enough new stories about Pfizer have accumulated since last year to do a roundup.   

Presented in chronological order....

Italy Demands Damages from Pfizer for Anti-Trust Violations

This story came out in May, 2014, via Reuters,

Italy said on Wednesday it was seeking more than a billion euros in damages from multinational drug companies following a ruling by the country's antitrust authority that their policies had been detrimental to Italy's national health service.

The health ministry said in a statement it was requesting a total 1.2 billion euros ($1.6 billion) from Novartis and Roche for the damages incurred in 2012-2014, and was requesting 14 million euros from Pfizer.

It cited several recent antitrust rulings that the companies' repeated anti-competitive actions had caused the national health service 'considerable damage'.

The specific charges against Pfizer were:

Italy's state council, the highest administrative court, in February ruled that Pfizer had abused its dominant position relating to the glaucoma drug Xalatan 'with a clear and persistent intention to suppress competition'.

At least in English language news sources, I have not seen how this turned out, but note that this was apparently an administrative court finding, not just a prosecutor's allegation.

Pfizer Accused of Overcharging for Pediatric Vaccines

This appeared in January, 2015, here via Ed Silverman's PharmaLot blog (when it was affiliated with the Wall Street Journal),

In a bid to widen access to vaccines, Doctors Without Borders is calling on Pfizer and GlaxoSmithKline to lower the prices for their pneumococcal vaccines to $5 per child in developing countries. The non-profit claims the drug makers are 'overcharging' donors and developing countries for vaccines that 'already earn them billions of dollars in wealthy countries.'

The non-profit, which regularly advocates for lower prices for medicines, maintains that, in general, the price to vaccinate a child against several diseases is now a 'colossal' 68 times more expensive than in 2001. In a new report, Doctors Without Borders attributes 45% of that increased cost to the price tags for pneumococcal vaccines sold by the drug makers. Pneumococcal disease, by the way, kills about 1 million children per year, mostly in poor and developing nations.

Think about the children.

The non-profit maintains that the current price tag makes it difficult to supply the vaccine to large numbers of children, and the drug makers have already received $1 billion in incentives to manufacturer the vaccine for developing countries. 'We think it’s time for Glaxo and Pfizer to do their part to make vaccines more affordable for countries in the long term, because the discounts the companies are offering today are just not good enough,' says Malpani in a statement.

Moreover, Doctors Without Borders warns that pricing may eventually make it harder for a growing number of middle-income countries to afford vaccines. Over time, some of these countries will eventually ‘graduate’ from the subsidized vaccine pricing established by Gavi and, when that happens, Doctors Without Borders estimates costs may rise up to six times what is the countries pay today.

The post included a statement from Pfizer about how hard it is to manufacture the vaccine, and an update to the post included a statement from Pfizer that it was already selling its pneumococcal vaccine, Prevenar 13, below cost to GAVI, which buys up vaccines and provides them to poor countries. A week later, again via (the old version of) PharmaLot, Pfizer announced an additional 6% price cut. Furthermore, Bill Gates, whose foundation supports GAVI, insisted that cutting vaccine prices would discourage pharmaceutical companies from investing in vaccine research and supplying products to poor countries, according to the Guardian.

However, neither Pfizer nor Mr Gates acknowledged how much money Pfizer already is making from Prevenar in developed countries, amounts which likely do far more than offset any losses in poorer countries. Specifically, in July, 2015 FierceVaccines reported that

The world's biggest vaccine by sales--Prevnar 13--just keeps getting bigger. And in doing so, the shot helped Pfizer notch 44% vaccines growth for the second quarter as the unit saw sales grow from $1.09 billion in last year's Q2 to $1.58 billion during the period this year.

For the quarter, the superstar pneumococcal disease-blocker notched a U.S. sales increase of 87% versus the same period last year, a jump Pfizer CEO Ian Read attributed to 'continued strong uptake' in U.S. adults.

Also,

Prevnar 13, which reeled in $4.29 billion in sales last year, is expected to grow to $5.83 billion in 2020 and remain atop the vaccines sales charts.

And,

The company is also working 'country by country' to broaden the vaccine's reach in G7 countries....

So there seems to be some evidence in support of the Doctors Without Borders claim that Pfizer could easily afford some small losses selling vaccines for use by poor children in less developed countries while it makes billions of dollars from vaccine sales in developed countries.  


Pfizer Settles Shareholder Suit for $400M

This settlement was just the latest that has resulted from allegations of illegal drug marketing by Pfizer.  As reported again by the redoubtable Ed Silverman in the old version of PharmaLot,

Pfizer has reached an agreement in principle to pay $400 million to settle a class-action securities lawsuit that alleged the drug maker illegally marketed several medicines and, subsequently, caused investors to lose money, according to a filing with the U.S. Securities and Exchange Commission.

The lawsuit alleged that, between January 2006 and January 2009, Pfizer marketed several drugs on an off-label basis. The medicines included the Bextra painkiller that was withdrawn from the market in 2005; the Geodon antipsychotic; the Zyvox antibiotic and the Lyrica epilepsy treatment.

The lawsuit, which was filed in federal court in 2010, alleged that the sales boost the drug maker received from the marketing prompted Pfizer executives to make 'false and misleading statements about Pfizer’s financial performance and sales practices [that] caused Pfizer stock to trade at artificially inflated prices.'

This settlement followed an even larger one back in 2009 when,

the drug maker revealed plans to pay $2.3 billion to resolve criminal and civil allegations that these drugs were marketed illegally.

We discussed that settlement in 2009 here, here, and here.  Note that the 2009 settlement included a guilty plea to a criminal charge (albeit to a misdemeanor), and was of allegations including paying kickbacks to doctors for use of Pfizer drugs.  So this additional settlement of deceiving investors just ices that cake. 

UK Competition and Markets Authority Stated Pfizer Abused Market Dominance

This story appeared in August, 2015, via the Telegraph,

The Competition and Markets Authority (CMA) has issued a statement of objections alleging the companies breached UK and EU law by raising the prices they charged for phenytoin sodium sold to the NHS.

In particular,

The CMA says that for years industry giant Pfizer, which is listed in the US, and Flynn, a Stevenage-based company, between them sold the drug at a price up to 27 times higher than it had been previously priced.

Before September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin.

Pfizer then sold the UK distribution rights for Epanutin to Flynn, which 'de-branded' the drug and started selling its version in September 2012. Pfizer continued to manufacture the drug, which it sold to Flynn at prices the CMA says were 'significantly higher' than those at which it had previously sold Epanutin.

The CMA claims Pfizer sold the drug at between 8 and 17 times its historic prices to Flynn, which then sold on phenytoin sodium at between 25 to 27 times more than the prices previously charged by Pfizer.

Before Flynn bought the rights for Epanutin, the NHS spent about £2.3m on phenytoin sodium capsules a year, according to the CMA. After the deal this spend rose to just over £50m in 2013 and more than £40m in 2014.

While the CMA findings were apparently "provisional," but the agency has the power to find that the law has been breached and "has the power to fine then up to 10pc of their global annual turnover - last year Pfizer had revenue of almost $50bn."  So this is the second government finding of anti-competitive behavior by Pfizer in a little over one year.

Pfizer Resists AllTrials Calls for Transparency

Late in August, 2014, per the Guardian,

Pfizer, one of the world’s largest pharmaceutical groups, has said it will resist demands from investors and transparency campaigners that it disclose results from all historical drug trials.

We have been discussing how pharmaceutical, biotechnology, and device companies have manipulated the clinical trials they sponsor to increase the likelihood that the results make their products look good, and may suppress trials whose results cannot be made to look good enough. This clinical research suppression and manipulation can lead to poor clinical decisions, may harm patients, and abuses the trust of patients who volunteer to participate in clinical research. This situation has led to the AllTrials campaign to make clinical research transparent (look here). However,

Pfizer said it had a 'longstanding commitment to clinical trial transparency' and it already published data for trials from 2007. Requests for earlier data are considered on an individual basis. But it added: 'We don’t believe that further investment beyond this would offer value to patients, health services or to our shareholders.'

This despite arguments above about the harms of research suppression.  Given how much money Pfizer has spent on lawsuits, including one above about allegations of its management's deception of shareholders, one might think it would be worth it for management to make a little investment in transparency.

Pfizer Found to Have Withheld Reports of Adverse Drug Events in Japan

Finally, reported in September, 2015 by in-PharmaTechnologist.com,

Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order. 

That website has copy protection so I cannot quote further, but the order involved 11 drugs, including Enbrel and Lyrica.  So here is yet another example of a government agency finding that Pfizer was less than transparent, if not overtly deceptive.

Summary

So in a little more than a year, Pfizer has been accused of anti-competitive practices raising drug costs in Italy, excess pricing of vaccines for use by poor children in undeveloped countries, deceiving its own investors about illegal marketing activities in the US, abuse of market dominance leading to excessive drug costs in the UK, stonewalling clinical trial transparency measures globally, and failing to disclose adverse drug effects in a timely manner in Japan.  This is on top of an already impressive record of misbehavior (See our summary of Pfizer mischief at the end of the post.)

However, as seems usual these days, no one at Pfizer who might have authorized, directed or implemented any of this bad behavior has ever seemingly paid any sort of penalty for it.  Instead, while this was going on, the top leadership of Pfizer just gets richer faster and faster.  In fact, in March, 2015, the Wall Street Journal reported the current Pfizer CEO's total compensation in 2014,

Pfizer Inc. said Thursday that Chief Executive Ian Read’s total compensation rose 23% last year, lifted by an increase in pension value that offset a reduced annual bonus and equity award.

Furthermore,

Mr. Read’s 2014 pay package totaled $23.3 million. The board raised the CEO’s salary to $1.83 million from $1.79 million but decreased his annual bonus by $400,000 and his equity award by nearly $1 million despite concluding that Mr. Read’s leadership during the year was 'outstanding.'

[Even though] Over the course of 2014, shares in the New York-based pharmaceutical company gained about 2% amid a 4% decrease in revenue.

It is not obvious that the rise in CEO pay is even remotely correlated to any rise in share-holder value.  Moreover, there seems to be a total disconnect between the rewards given the CEO and the ethical record of the company he leads, especially since Pfizer, which calls itself "one of the world's premier pharmaceutical" corporations, announces its aspirations thus,

we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

Never mind all those pesky allegations of overpricing, anti-competitive practices, deception and opaqueness, and never mind that current executives are becoming exceedingly risk in part from the continuation of such practices.  So it seems the board of Pfizer will just continue handing its executives piles of money, despite, or for all I know, because of the company's continuing bad behavior.  Given these incentives, is it any wonder that the bad behavior continues?  Pfizer seems to be just another example - albeit a big one - of how health care is dominated by an oligarchy of unaccountable leaders who continue to demonstrate their impunity hidden by aspirational but hollow public relations and marketing.

Of course, it is doubtful such bad behavior would continue if there risks of external penalties, e.g., from law enforcement.  But there never seem to be any.

In the past, US law enforcement authorities have announced they would use the responsible corporate officer doctrine, a legally tested rationale for prosecuting corporate managers for bad behavior by those who report to them (e.g., in 2010, look here),  But it seems they have never done so, at least in cases involving large health care organizations.  Last week, the US Department of Justice announced it would start going after executives of companies that misbehave, and would press the companies to give up the name of responsible executives in exchange for more lenient treatment of the companies themselves (e.g., see this report in the NY Times).  Meanwhile, however, the march of legal settlements for bad behavior in health care continues, absent any penalties for organizational leaders who might have authorized or directed it, much less for those who simply put incentives in place to foster bad behavior while looking away from what those incentives inspired.    

I hope these current promises by law enforcement officials are not as hollow as earlier ones, because continuing our society's continuing failure to rein in corrupt business practices via law enforcement and regulation may lead a desperate populace to more radical approaches. The UK Labor Party just elected a Marxist leader (see this Reuters report.)  One wonders how long it will be before anger at the larger oligarchy, of which health care leadership is merely a part, boils over in other countries, and in more radical ways.

Instead, we continue to advocate for true health care reform with the immediate priority of changing how health care organizations are led, and ensuring leadership that upholds health care values, is willing to be accountable, and is open, honest, transparent and ethical.  We still may have time to reform.  But the reform will have to be big and true.  If not, moderate voices may be drowned out, and the results may be worse than anyone could imagine.

Appendix - Pfizer's Previous Settlements


For all our posts on Pfizer, look here.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,
- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,
- Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).
- The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here). 
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).

The Latest Example of the Anechoic Effect - AllTrials US Initiative Launches to Deafening Media Silence

Every now and then, someone tries to persuade me how much more open discussion of various kinds of recent unpleasantness in health care has become in the US. I admit there has been more media attention to certain issues, but unfortunately must maintain that the issues most likely to be make those who profit the most from our current health care system uncomfortable remains anechoic. Now I have my latest example

AllTrials

AllTrials is a UK based organization that advocates for registration and public reporting of all clinical trials.  AllTrials explains the reasons for this simply:

Clinical trials are the best way we have of testing whether a medicine is safe and effective. They can involve thousands of people, patients and healthy volunteers, and take years to complete.

Results from around half of all clinical trials remain hidden

Trials with negative results are twice as likely to remain unreported as those with positive results. This means that people who make decisions about medicines don’t have full information about the benefits and risks of treatments we use every day. Read our 8 page briefing note on missing trials here.

Thousands of clinical trials have never been publicly registered

There is no complete list of all clinical trials, so we don’t even know that some trials have taken place, never mind what was found in them.

The contributions of hundreds of thousands of patients are unused and unusable

Patients volunteer for clinical trials because they expect that what was found in the trial will be of use to doctors who make decisions about treatments and to researchers who are studying the condition. Trial participants have told us that the culture of secrecy around clinical trial reporting is a betrayal of their trust. Read their words here.

AllTrials has garnered considerable support in the UK.

On Health Care Renewal, we have been discussing the problem of suppressed clinical research for a long time, and have made similar arguments.  Up to now, I have chosen not to post a lot about AllTrials because as a UK based movement, it was getting considerable press coverage in the UK, and garnering considerable support there.  I did not think the movement needed what meager help a Health Care Renewal post would provide.

The Anechoic AllTrials USA Launch

But now, AllTrials has come to America.  And it perhaps should not be a surprise that its advent on this side of the pond generated essentially no notice, particularly, no notice in the US mainstream media or in US scholarly health care and medical journals.  

The announcement of the AllTrials US initiative appeared on the organization's website, and on the Biomed Central blog..  A press release appeared on the PRNewswire.  The American Academy of Family Practice (AAFP) announced its participation on its website.   The move received support from a post on the PLoS Public Health Perspectives blog, and perhaps surprisingly, from the UK based Financial Times.

Otherwise, at least according to my web searching efforts, there has been silence.  I found nothing in major media outlets, nothing in medical journals, and even nothing on the websites of the few US professional societies other than the AAFP that are listed as AllTrials USA supporters (that is, the American College of Obstetricians and Gynecologists, American College of Physicians and the American College of Chest Physicians). 

The Anechoic Effect Continues

We have frequently discussed the anechoic effect, the phenomenon that information or discussion that could challenge or discomfit the powers that be in the US health care often generates no echoes.  In effect, suppression of clinical research in itself is an example of the anechoic effect.

Why might even discussion that allows that clinical research might be suppressed invoke the cone of silence?

Looking at AllTrials literature may not be too helpful in providing an answer to this question.  The AllTrials organization is adept at discussing the reasons that clinical trials should not be suppressed, but has been very diplomatic about why they actually are suppressed.

On the other hand, its seems logical that when clinical trials are sponsored by organizations, such as pharmaceutical, biotechnology and device companies, to assess their own products, company management might get strong incentives to ensure that such research ends up making their products look good.  Sponsored research could be manipulated (in terms of the formal hypotheses it tests, its design, implmentation, and analysis) to increase the likelihood that the results would favor the sponsor.  When all else fails, the sponsor could suppress research that fails to make its products look good.  There is at least suggestive evidence that this occurs.  For example, see the now classic study by Turner et al that showed that clinical research sponsored by pharmaceutical companies to assess their own antidepressants were much more likely to be published if the results favored their own products.

So I suspect that the management of many health care organizations, particularly but not exclusively pharmaceutical, biotechnology, and device companies may not be very comfortable discussing the problem of suppressed research, or with measures designed to uncover such research.  Further, as we have discussed frequently, such companies have financial arrangements with individual health care professionals, health care academics, academic health care organizations, and a variety of other organizations such as medical societies and patient-advocacy groups.  These arrangements can constitute individual and institutional conflicts of interest.  It is not impossible that such financial relationships might influence such individuals and groups to want to avoid the topic of research suppression.

Yet it is striking that the important AllTrials USA initiative, an offshoot of an organization that has certainly got some attention in another English speaking country, has generated NO media or medical/ health care journal coverage in the US so far.

We cannot expect any real improvement in the dysfunctional US health care system while it still appears to be taboo to discuss many of its most dysfunctional aspects.  True health care reform requires open and honest discussion of these issues, that is, we need real free speech and a real free press in health care.  

ADDENDUM (21 August, 2015) - This post was republished on the Naked Capitalism blog.