Showing posts with label pharmaceuticals. Show all posts
Showing posts with label pharmaceuticals. Show all posts

Friday, October 4, 2013

Use of Psychological Manipulation of Physicians to Sell Pharmaceuticals: The Drug Representative as "Den Mother"

We have discussed, most recently here, how marketers of health care goods and services use deception and psychological manipulation to sell their goods.  Physicians, of course, are particular targets of marketers of drugs and devices. 

A vivid anecdote showing how this works just appeared on a New York Times blog.  It may be easier to recall that psychological theories:

In the social and culinary wasteland that was residency training, it had been easy for Cheryl, a bubbly brunette in her mid-30s, to become our den mother. She never tired of listening to our grousing, had unerring taste in take-out, made it a point to come to our parties when invited and every so often brought in a plate of her homemade brownies.

But Cheryl was no den mother. She was a pharmaceutical rep.

That she managed to slip a plug for her wares into every conversation or tuck copies of studies promoting her product into our white coat pockets as we polished off her brownies was awkward. But we always overlooked the salesmanship because it was such a familiar part of our residency routine. As trainees in a large teaching hospital, we knew numerous sales reps by name and the products they peddled; and it was odd, even disappointing, to go to an educational conference where one of them was not standing next to a table laden with tchotchkes, information brochures and free take-out.

 But in retrospect, such docile acceptance was problematic. In an environment where no one, including senior doctors, ever questioned the presence of sales reps, we didn’t think too hard about why they might have been as friendly and helpful as they were. We didn’t ask where the money for all these giveaways was coming from and we were rarely curious about who these reps actually were (I only ever knew their first names).

It wasn’t that I or the other residents preferentially prescribed their products. But I do know that more than once when faced with a decision about what to prescribe, the first thought that came to mind was not what I needed to do to find the latest evidence-based recommendation, but what Cheryl had just told us over lunch. 

All of this became painfully clear after Cheryl suddenly disappeared. At first, the other trainees and I thought she had been fired, so we avoided bringing her absence up with the rep who replaced her. But when I ran into someone from her company at a national medical conference a year later, I learned otherwise.

'Oh, she got promoted,' the rep said, smiling broadly. 'Now she’s an executive in the central office.' 

Since Ahari and Fugh-Berman wrote and testified about the cynical tactics used in the marketing of drugs and other medical products years ago (look here, here, and here), it is now inexcusably naive for doctors to believe that drug (or device) representatives are their friends, no matter how friendly they appear.  Drug and device reps are trained to appear to be likable.  They may look like sympathetic friends, glamorous companions, or in this case, den mothers.  But as Sah and Fugh-Berman noted (look here), likability is a ruse to sell products.  Brownies are supplied to give the appearance of warmth and comfort, and to generate feelings of reciprocity.

How well it works appears above: "the first thought that came to mind was not what I needed to do to find the latest evidence-based recommendation, but what Cheryl had told us over lunch."  That it works well is demonstrated by Cheryl's promotion to an executive office.

As long as physicians remain trusting, naive, or foolish in their approach to deceptive marketing, there will be more use of needlessly expensive, and sometimes needlessly toxic drugs, and more drug reps made into well-paid executives. 

Thursday, May 23, 2013

The Best Governance for Medicines ... is in Thailand

The Best Health Care System in the World? 

Here in the US, a lot of people have been convinced that we have the best health care system in the world.  For example, during the 2012 US presidential campaign, Politi-Fact reported,


House Speaker John Boehner, R-Ohio, says the health care law signed by President Barack Obama -- and upheld by the U.S. Supreme Court -- imperiled the nation’s health care system.

'Gov. Romney understands that Obamacare will bankrupt our country and ruin the best health care delivery system in the world,' Boehner said, during the July 1, 2012, edition of CBS’ Face the Nation.

Boehner wasn’t the only one making that claim on the Sunday talk-show circuit. On Fox News Sunday, Senate Minority Leader Mitch McConnell, R-Ky., added that the U.S. has 'the finest health care system in the world.'

More recently, as the Huffington Post reported,


Sen. Jeff Sessions (R-Ala.) charged Thursday that Obamacare is destroying the 'greatest health care system the world has ever known' and that it was 'horrible' for anyone to suggest Americans receive anything less than the best care, even though they die younger on average than people in many other countries.

'This is just one example of what happens in this country when people in Washington take on the arrogant view that they know how to fix the health care system -- one of the most massive, complex, marvelous systems the world has ever known,' Sessions said on the Senate floor.

One would expect that the greatest health care system in the world would have the greatest pharmaceutical industry in the world too.  In fact, as noted by Politi-Fact,  that is pretty much what Congressman Boehner asserted,

 Boehner’s office also noted that wealthy foreigners flock to the U.S. to receive care because of its cutting-edge facilities, and that the U.S. is among the leaders, if not No. 1, in medical research and pharmaceutical development.

Not the Best Governance for Medicines in the World

A recent article from the National News Agency of Malaysia will probably not get a lot of attention in the US, or other developed countries, but it does suggest another reason to be very skeptical about shouts of "USA Number 1" at least applied to health care.  The article's main point was:

The World Health Organisation (WHO) has praised Thailand for the world's best governance for medicine, Thai News Agency (TNA) reported.

Public Health Minister Dr. Pradit Sintawanarong, who is attending the 66th World Health Assembly in Geneva, Switzerland, from May 20-28, told journalists on Wednesday that the WHO has asked Thailand to co-organise a meeting on good governance for medicine, as the Thai Kingdom is considered the world's most advance in governance for medicine and should be a good example for other countries.

Dr. Pradit, who was invited by the WHO to open a meeting on Thailand's governance for medicine and health systems, held as part of the 66th World Health Assembly, acknowledged that the WHO has also asked Thailand to share experiences in another side meeting on 'Good Governance in the Pharmaceutical Sector:The Case of Thailand and Malawi'.


Again, a lot of people think of the US health care system as a model of the rest of the world.  Here is one little bit of data that maybe it should not be the model for "governance for medicine."  Of course, that phrase itself is almost never used here.  Its definition, however, should be instructive.

The World Health Organization has had a small "Good Governance for Medicines" program since 2004.  We first discussed it here in 2008  On the program web-site, its goal is defined:

contributing to health systems strengthening and preventing corruption by promoting good governance in the pharmaceutical sector.

Specifically the programme aims:
-To raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda
- To increase transparency and accountability in medicine regulatory and supply management systems - To promote individual and institutional integrity in the pharmaceutical sector
- To institutionalize good governance in pharmaceutical systems by building national capacity and leadership.

So if Thailand received recognition for having the best governance for medicines, the implication is that the US does not.

In fact, we and other dissidents have documented a host of problems with individual and institutional integrity in the pharmaceutical sector, lack of transparency and accountability in medicine regulatory and supply management systems, and actual corruption in the pharmaceutical sector.  Some of the most recent big examples on Health Care Renewal since December, 2012, include:
-  the CEO of drug and biotechnology company Amgen collected tens of millions of dollars while his company settled lawsuits alleging it gave kickbacks to doctors, pharmacists and others to use potentially dangerous medicines (post here)
-  Pfizer's 14 legal settlements since 2000, including settlements of allegations of fraud, illegal promotion of hazardous drugs, kickbacks given to physicians, bribery of foreign officials, etc.  The biggest was for $2.3 billion.  In one case, the company was convicted of being a racketeering influenced corrupt organization (RICO) (post here).
- Three settlements in the US by GlaxoSmithKline in 2012, of allegations including deceptive marketing to hide drugs' adverse effects, improperly preventing generic competition, and a $3 billion settlement for deceptive marketing and improper promotion of multiple drugs (post here).
- Eli Lilly settled allegations that it bribed foreign officials.  (In 2009 it pleaded guilty to criminal charges arising from deceptive marketing of Zyprexa) (post here)
- After making two settlements of overcharging the US government in 2007 and 2009, Sanofi settled US allegations of giving kickbacks to doctors (post here)..
-  The pharmaceutical paid "key opinion leader" who was most influential in promoting widespread use, and probably overuse of opiates, admitted it was all "misinformation" (post here).

See also our posts on bribery, kickbacks, fraud, crime, and corruption, not to mention deception, stealth marketing, conflicts of interest, institutional conflicts of interest, etc.

Participatory Democracy in Health Care


So good for the Thais for apparently doing much better with far fewer resources.  One reason seems to be that the government has made good governance for medicines, defined as above, a big priority:

According to the public health minister, the Thai government and his ministry have adhered great importance to good governance for medicine (GGM) and health systems and Thailand has also joined the WHO's campaigns on the GGM from the first stage, concerning the assessment of the situation and the installation of relevant systems.


I can also speculate that one reason they have done better is their conscious effort to enlist the public at large in discussing and setting the direction of their health care system.  For example, as we discussed in 2009,  Thailand has set up by law a National Health Assembly, with its stated goal to be:

an instrument as well as a learning process to develop participatory public polices on health and pushing for practicability.

Assemblies have been held yearly since 2008.  A detailed report on the 2008 assembly is here. [Rasanathan K, Posayanonda T, Birminghan M et al.  Innovation and participation in the first National Health Assembly in Thailand. Health Expectations 2012; 15: 87-96].  The most recent was in December, 2012 (look here.)  

Such a mechanism for broad public input into health care does not obviously occur in the US.  Instead, we have corporations spending billions on lobbying, public relations, stealth advocacy, and campaign contributions.  We have the constant interchange of top government and corporate health care leaders via the revolving door.

We do not have any significant public discussion of good governance for medicines, or anything like it.  (The few, rare exceptions about which I know are the recent Healthy Skepticism meeting on Selling Sickness, and the now yearly meetings organized by PharmedOut.org)  Discussion of deception, conflicts of interest, crime and corruption affecting large health care organizations is muted and anechoic.  I know of precisely one course on health care corruption in any US medical, public health, or health administration school (look here, and its focus is on developing countries.)

Time to head to Bangkok?....  But if we all cannot... 

In the US, we will not have a chance of meaningfully improving our health care system until we start listening to unbiased health care professionals and academics (in particular, who have not been paid off by vested interests),  civil society organizations, and people and patients at large, and stop getting all our insight from corporate executives, their cronies, and their paid experts.  We will not have a chance until we allow discussion of all the problems, including bad leadership and governance, dishonest and deceptive practices, conflicts of interests, and outright crime and corruption.  We will not have a chance until we put our priority on patients' and the public's health, not the vested interests of those who have gotten rich off the current dysfunctional system. 


.

Tuesday, March 19, 2013

Doctors' Dubious Excuses for Taking Pharmaceutical Companies' Money

Pro Publica has updated their database of payments by pharmaceutical payments to physicians and organizations.  It now has data from 15 companies totaling more than $2 billion from 2009 to 2012.

To accompany Pro Publica's report, a number of news outlets wrote about payments given to local or regional doctors.  These included, in semi-random order, the Los Angeles Daily News (via the Inland Valley Daily Bulletin), the Salt Lake (City, Utah) Tribune, the San Jose (California) Mercury News, NewsChannel5 in Nashville, Tennessee, the Pasadena (California) Star-News, the Bergen and Passaic, New Jersey Record Herald via NorthJersey, the Philadelphia Inquirer, and the Columbus (Ohio) Dispatch.

The combined reports showed that many physicians, including prominent academics and community practitioners, are still getting a lot of money from pharmaceutical firms.  Since Pro Publica was only able to get data from some US drug companies, albeit those who accounted for 47 percent of US drug sales, it is likely that many more doctors than those in the data base got such payments, and the doctors in the data base may have gotten more money from companies that do not report their payments.  In addition, it is likely that many more doctors get similar payments from medical device companies, health care information technology companies, and other for-profit corporations that promote health care products and services.  

We had discussed Pro Publica's initial reporting from its database here.  While there is evidence that most payments to doctors by pharmaceutical companies are intended to promote marketing, we discussed here how some doctors rationalized their payments as fully professional and proper.

Now the updated reporting has provided many examples of - not to put too fine a point on it - physicians making dubious excuses for their acceptance of payments, often large, from pharmaceutical companies. Their themes included

It's Education, What Could Possibly Go Wrong?

From Pro Publica,

[Dr Rakesh] Jain, of Lake Jackson, Texas, has earned $582,049.  [Dr Vladimir] Maletic, of Greer, SC, made $527,850, according to Dollars for Docs.

So,
Jain said he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him.

'I am not a marketer, I am an educator,' Jain said.

Also
Maletic said he speaks about treatments for mood disorders, schizophrenia and sleep-wakefulness disorders because he believes that 'good quality education about pharmaceutical products may be beneficial to both physicians and their patients.'

The LA Times found someone with a similar opinion.

'Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,' said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  'Now they must provide some educational content.'

Jeng was paid $80,500 by Pfizer last year for several speaking engagements. As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics. Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That's why he agrees to speak.

'We (speakers) provide education when a new antibiotic does get released,' he said. 'There needs to be education among doctors on how to use this new antibiotic.'


In addition, the Salt Lake Tribune noted that 

[Dr Eliot] Brinton received two of the single largest payments in Utah, both in excess of $85,000, for promoting drugs by GlaxoSmithKline, ProPublica’s database shows. He describes the lectures as educational and based on science.

'I love the science and I love to teach. And doctors are glad to better understand the drugs and how to use them. I’m careful not to act as a cheerleader,' he said. 'If I’m a shill for the drug company I lose my integrity and integrity is really all I have to offer my patients and the drug companies.'

The physicians above all asserted that since their activities were "educational," they must be worthwhile.

Note that the ostensibly educational activities described above all appear to be "drug talks," that is talks sponsored by the drug companies, probably through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education.  Since the publication of "Dr Drug Rep" in the New York Times in 2007, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.) 

In addition, pharmaceutical companies often pay physicians deemed to be "key opinion leaders," whose opinions are promoted supposedly for their brilliance and erudition.  However, as noted here and here, the companies buying their services believe they have bought the services of sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how company keaders view key opinion leaders as marketers.

Given the volume of evidence about drug talks, speakers' bureaus, and the marketing purposes of key opinion leaders, the assertion that because they were in some sense educational, these doctors' corporate financed talks were worthwhile is at best a silly excuse.

More formally, it may arise from a logical fallacy.  The doctors appeared to be arguing that education is an unalloyed good.  However, obviously not all education is good education, or unbiased education. Specifically in this case, logic, and evidence from several cases in which pharmaceutical companies' intentions as documented in communications revealed in litigation (see examples here) suggest that these companies pay physicians for education that they believe serves marketing purposes.Thus the doctors seem to be using the composition fallacy, the logical fallacy that an entire class (in this case, all of education) can be judged by some of its members (examples of unbiased, accurate, good education.) 



It's Research, What Could Possibly Go Wrong? 
Similarly, the doctors who get paid to do research say it's all about the research.  The Salt Lake Tribune reported on
CRI LifeTree Research, which has received at least $3.4 million in drug company payments since 2009, according to ProPublica. 

Co-founder Lynn Webster, an anesthesiologist, is listed as having received the single largest payment in the state: $1,687,771 from Cephalon, a big maker of pain medications. Only three other doctors in the country received more from Cephalon.

Nationally, Webster is among the top 50 for single largest payments received, behind marquee hospitals, such as the Mayo Clinic, Cleveland Clinic and Duke and Harvard Universities.

A nationally recognized expert in pain management, Webster is under investigation by the U.S. Drug Enforcement Administration, which is looking into opioid overdose deaths of patients of his former pain clinic. A Senate Committee is probing his financial ties to Big Pharma.

Webster insisted,

Research payments to him cover overhead and other costs, including his salary as a lead researcher, he said. 

'Research inevitably leads to better education, better systems and better therapies — things that are indispensable for medical advancement and quality care,' he said. 

The Pasadena Star-News provided this version,

Pasadena-based plastic surgeon John Edward Gross received more than $770,000 from Allergan, the maker of Botox and some breast implants.

In 2011-12, Allergan paid Gross to conduct research, consult, serve on health care panels and business travel.

'What I'm doing for Allergan is to advance breast surgery,' said Gross, a board certified surgeon and a former chemical engineer. 'Much of the research you do is industry-supported. They have a motivation to make better and new products.'

It is pretty amazing to see the notion that all clinical research is irreproachable in print.  We and others have documented huge numbers of cases and volumes of evidence that clinical research may be manipulated, and, if necessary, suppressed to support the commercial goals of those who make products or provide services assessed by such research.  In fact, the prestigious Institute of Medicine's report on Conflict of Interest in Medical Research, Education and Practice included the recommendation (4.1) that "individuals may not conduct research with human participants if they have significant financial interest in an existing or potential product or a company that could be affected by the outcome of research."  Given the volume of this evidence, the assertion that all pharmaceutical company clinical research should be irreproachable is just plain silly.

Again, formally the physicians' arguments, if they should be dignified with that name, seem to arise from the same logical fallacy discussed above.  The underlying argument seems similar to that made above about education: "I am doing research.  All research is good, unbiased, helpful to patients.  So what I am doing is good, unbiased, helpful research."  So it appears the composition fallacy again was in play.

It's Not Really My Money

The San Jose Mercury News provided this example,

The database links Dr. Gurkirpal Singh to more than $248,000 in Pfizer payments it lists for speaking, consulting, travel and meals since 2009. He said all the money went to Institute of Clinical Outcomes Research and Education in Palo Alto, where he is the chief scientific officer. Singh said the money paid for research.
'I receive nothing -- let me be very clear on that,' said Singh, who is an adjunct clinical professor at Stanford University.

The Columbus Dispatch added,



 Dr. Henry Nasrallah, a psychiatrist at the University of Cincinnati, netted $647,341 in speaking and consulting fees from drug companies, ranking him as Ohio’s top recipient of such payments over that four-year period. Cincinnati’s College of Medicine put that money toward his $222,232 annual salary.
'The (pharmaceutical) companies have a signed agreement with the university for my activities, not with me personally,' Nasrallah wrote in an email to The Dispatch.

'This is another reason why I maintain scientific and clinical impartiality about the various drugs I teach, because I do not have a direct personal gain,' wrote Nasrallah, a former chairman of Ohio State University’s psychiatry department.
Really, the boss doesn't care whether he brings in any money?
These doctors seem to be denying that money is fungible.  In other words, they seem to be arguing that money going to the organizations that pays them is different from money going directly to them, and that their bosses do not in fact care whether their activities bring any revenues to the organization.  This just flies in the face of common sense.


Someone Needs to Pay

NewsChannel5 was able to interview the top earner on the Pro Publica list, Dr Jon W Draud, who said among other things, 

it was only fair to accept payments for his speaking engagements because it makes up for what he would otherwise make while working at his practice.
 'It's not essential, I suppose, but I consider it a reasonable, fair compensation for being gone and traveling, and spending time away from my home and family,' Draud said.
If Dr Draud was providing education, a useful service, it seems reasonable that someone should pay for it.  However, he appears to beg the question of who should pay for it?  Underlying this question is the concern that since it was pharmaceutical companies, not students, who were paying, the education was being done primarily to benefit the former, through marketing, rather than the latter.  The apparent argument, that because it is not reasonable to get paid for services, any source of payment is acceptable, is again just plain silly. 


Who Cares About Money?

NewsChannel5 also reported that Dr Draud said

 accepting so much money did not create a conflict of interest between him and his patients. He said the information he gives out was not biased towards the drug companies.

However, the Institute of Medicine report on Conflict of Interest in Medical Research, Education and Practice defined conflict of interest as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest."  Asserting that receiving over $1 million could not create even a risk that his educational presentations were biased towards the interests of those who gave him that money seems like simple denial.  

The FDA Said it Was True

Top earner Dr Draud also said according to NewsChannel5,

 It has to be vetted by the FDA as being fair, balanced and non-biased toward the pharmaceutical company....

From the Philadelphia Inquirer, re Dr Warren S Joseph, a podiatrist who received over $650,000

Joseph acknowledged the payments in an email to Philly.com.

'All of my lectures given for the Pharma industry follow strict FDA guidelines and are consistent with the corporate integrity agreements entered into between the companies and the government,' Joseph said. 'There is full disclosure of this fact at all lectures.'
 These justifications appear to be just plain wrong.  As far as I know, the US Food and Drug Administration does not pre-approve "drug talks" given by physicians for pharmaceutical companies.

By the way, the statement by Dr Joseph approaches self parody.  As we have discussed, corporate integrity agreements are usually the products of legal settlements of charges of wrongdoing.  Drug companies do not sign such agreements because of previous good behavior.  Moreover, I have never heard of such an agreement that required pre-approval of drug talks, either. 

 Trust Me, I'm an Expert

 As reported by NorthJersey,

One of the top recipients in North Jersey was Thomas Dayspring, an internist and expert in cholesterol management, who earned just under $400,000 from Merck and GlaxoSmithKline. Dayspring said he was paid for lectures at conferences for doctors arranged by the drug companies, as well as continuing medical education programs.

'I’ve logged over 2 million miles, all over the world and in all 50 states,' said Dayspring, who served as the director of the North Jersey Institute of Menopausal Lipidology in Wayne until last summer. 'Guys like me who are nationally known attract a big audience. Not every speaker can trot out a CV like mine.'
New Jersey, you gotta love it.  The most charitable characterization of this is an appeal to authority, albeit an amazingly egotistical one. 

Summary

 Two years after Pro Publica's report, pharmaceutical companies are continuing to pay substantial sums to physicians and other health professionals, nominally for education and research.  Because these arrangements are financially beneficial to the professional recipients of the money, and likely financially beneficial via their marketing effects  to the companies that provide the money , it should be no surprise that they are continuing in the absence of any regulatory restrictions.

What is saddest about the latest reporting is the silliness of the excuses made by the conflicted physicians.  Professionals with four years of education post-college, and multiple years of experience, and who are often respected as academics or practitioners ought to be able to reason and argue better than they did in the examples above.  Of course, people who make a lot of money often come to believe they really deserve it.  And conflicts of interest produce conflicted thinking.  As Joe Collier wrote in the BMJ, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." (Look here.)

The IOM  report  on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry.  This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts.  However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research.