Archive for the 'Big Pharma' Category

Selling Sickness 2013: People Before Profits: Call for Papers

Add a comment

Our colleague Dr. Leonore Tiefer forwarded us a call for papers for the Selling Sickness 2013 conference which will take place from Feburary 20-22, 2013 in Washington D.C.

Selling Sickness 2013

Selling Sickness 2013 is the third conference in a series devoted to disease mongering.  Selling Sickness 2010 was held in Amsterdam from October 7-8, 2010. The Inaugural Conference on Disease-Mongering took place in Newcastle, Australia  from April 11-13, 2006. Videos of the talks from the 2010 conference are available on-line. The papers from the 2006 Conference have been published in a PLoS Medicine theme issue.  Dr. Tiefer has been featured previously in the Portal for her role in the film Orgasm, Inc.

For readers who may not be familiar with the concept of disease mongering, here is a synopsis drawn from the introduction to the PLoS theme issue:

Disease mongering is the selling of sickness that widens the boundaries of illness in order to grow markets for those who sell and deliver treatments. It is a process that turns healthy people into patients, causes iatrogenic harm, and wastes precious resources [1]. Disease mongering is the contemporary form of “medicalisation.” It is a process now driven by both corporate and professional interests, and it has become part of the global debate about health care. International consumer groups now target drug company–backed disease mongering as a wasteful threat to public health [2], while the global pharmaceutical industry has been forced to defend its promotion of “lifestyle” medicines for problems like slimming and sexual difficulties [3].

Call for Papers

Selling Sickness 2013 will create an interdisciplinary forum that encourages collaboration, networking, dialogue, and audience participation as well as personal and professional development. It is intended for academic scholars, healthcare reformers, consumer organizations and advocates, and progressive health journalists.

Possible submission topics include:

  • Misleading marketing and social media Over-treatment and health screening policies Industry and government whistleblowers
  • Ethics and standards in professional education and journalism
  • New models for drug development and testing Emerging conflict of interest areas
  • Personal and professional narratives (e.g., accounts of involvement in Big Pharma reform and the “Choose Wisely” Initiative)
  • Ramifications of disease mongering on public health
  • Possible presentation formats: workshops, oral presentations, panels/structured discussions, and poster presentations. Descriptions of presentation formats and submission requirements are available on the conference’s website. Submit ideas here.

Submissions from students and young activists are welcome.

Deadline for Submissions is OCTOBER 1, 2012.

For questions or for more information, please visit www.sellingsickness.com or email Jessica@sellingsickeness.com.

Posted by Matt Anderson, MD

F29: OWS Protests Pfizer and ALEC on Leap Day (2/29/2012)

Add a comment

Note from the Editor: Pfizer offers a especially outrageous case of a company which committed massive crimes and did not face the full penalty. Here, briefly is the story:

In 2009 the US announced a $2.3 billion dollar settlement with Pfizer’s for the marketing practices related to several drugs including Bextra, a drug taken off  the market in 2006 because of concerns over cardiovascular safety.  In their statement on the case the FBI noted that Pfizer: “promoted the sale of Bextra for uses and at dosages the Food and Drug Administration (FDA) specifically declined to approve for safety reasons.”   The settlement involved the largest criminal fine ever imposed in the US.

Both HHS and the FBI emphasized that this was (to use the FBI’s words): “a clear message that the FBI and our partners will not stand by and let any manufacturer peddle their prescriptions or products for uses beyond their intended—and federal government-approved—purpose.

But the back story is not so simple.  If a health care company is convicted of fraud it is automatically excluded from the Medicaid and Medicare programs for several years.  This is the law.  But CNN later reported that prosecutors felt an exclusion from Medicare and Medicaid would bankrupt Pfizer, a company they deemed “too big to fail.” So the Feds found a way to help Pfizer avoid this penalty.  They allowed Pfizer to create a shell company – Pharmacia & Upjohn Co. Inc. – which would plead guilty to the fraud and be excluded from Medicare and Medicaid; for the rest of the company it was business as usual.  It was – in the words of CNN – like having an imaginary friend who takes the rap for you when you do something wrong.

In short this was a “clear message” that when corporations are too big, they are above the law.  When this happens something is very wrong with our democracy and it is time to take to the streets.  For us in NYC the exact time is 2/29/2012 @ 10AM.

Protest against Pfizer’s profiteering and support for ALEC (American Legislative Exchange Council)

When:   Wednesday, February 29, 10 AM

Where:  Assemble at 42nd Street and First Avenue (Robert Moses Playground)

In fighting corporate greed and corruption, Occupy nationwide is holding actions on Wednesday February 29 to raise awareness about the destructive political activities of the American Legislative Exchange Council (ALEC) and the corporations, Pfizer among them, that run it.

The two main targets in New York City are Bank of America and Pfizer, and Healthcare for the 99% is leading a protest at Pfizer, which sits on ALEC’s Board, to highlight how its business practices as well as its role in ALEC reveal excessive corporate greed at the expense of human needs.

This is in essence a march along 42nd Street from 1st Avenue to 6th Avenue:

9:30-10:00 AM:   Meet up at Fitst Avenue and 42nd Street (Robert Moses Playground at the north side Tudor City);

10:00-11:00 AM: March to and protest (moving picket) outside Pfizer at 235 East 42nd Street between 2nd-3rd Ave;

11:00-12:00 PM: March to Bryant Park, join other feeder marches, staging for…

12:00-??:?? PM: Step-off for roving actions at Bank of America branches and ending at BOA Tower.

Download the Call to Action for this Protest here: ALEC-Pfizer_SDTC_Call-To-Action

For more on NYC OWS F29:  http://www.nycga.net/events/event/national-day-of-action-shut-down-the-corporations/

For more on ALEC: http://alecexposed.org

For more on nationwide F29 Action: http://www.shutdownthecorporations.org/

posted by Matt Anderson, MD

Orgasm Inc opens in NYC February 11th, 2011

2 Comments

A former teacher and colleague, Dr. Leonore Tiefer, sent along an announcement about the opening – just in time for Valentine’s Day – of a documentary entitled Orgasm, Inc.  Dr. Tiefer is one of the interviewees in the movie which examines the search by big Pharma for a female Viagra. It will open in both New York City and Chicago on Friday, February 11th. In New York it will be showing at the Quad Cinema.  Dr. Tiefer and the filmmaker  Liz Canner will be answering questions after the 6:45 show on Friday 2/11  and the 2:40 and 4:20 shows on Sunday 2/13.   You can view the film’s trailer here.

Dr. Tiefer is one of the authors of the 2004 New View Manifesto which challenges the medicalization of female sexuality.  Here is a quotation from the introduction to the Manifesto:

We believe that a fundamental barrier to understanding women’s sexuality is the medical classification scheme in current use, developed by the American Psychiatric Association (APA) for its Diagnostic and Statistical Manual of Disorders (DSM) in 1980, and revised in 1987 and 1994. [ 2 ] It divides (both men’s and) women’s sexual problems into four categories of sexual “dysfunction”: sexual desire disorders, sexual arousal disorders, orgasmic disorders, and sexual pain disorders.

These “dysfunctions” are disturbances in an assumed universal physiological sexual response pattern (“normal function”) originally described by Masters and Johnson in the 1960s. [ 3 ] This universal pattern begins, in theory, with sexual drive, and proceeds sequentially through the stages of desire, arousal, and orgasm.

In recent decades, the shortcomings of the framework, as it applies to women, have been amply documented. [ 4 ] The three most serious distortions produced by a framework that reduces sexual problems to disorders of physiological function, comparable to breathing or digestive disorders, are:

1) A false notion of sexual equivalency between men and women. Because the early researchers emphasized similarities in men’s and women’s physiological responses during sexual activities, they concluded that sexual disorders must also be similar. Few investigators asked women to describe their experiences from their own points of view. When such studies were done, it became apparent that women and men differ in many crucial ways. Women’s accounts do not fit neatly into the Masters and Johnson model; for example, women generally do not separate “desire” from “arousal,” women care less about physical than subjective arousal, and women’s sexual complaints frequently focus on “difficulties” that are absent from the DSM. [ 5 ]

Furthermore, an emphasis on genital and physiological similarities between men and women ignores the implications of inequalities related to gender, social class, ethnicity, sexual orientation, etc. Social, political, and economic conditions, including widespread sexual violence, limit women’s access to sexual health, pleasure, and satisfaction in many parts of the world. Women’s social environments thus can prevent the expression of biological capacities, a reality entirely ignored by the strictly physiological framing of sexual dysfunctions.

2) The erasure of the relational context of sexuality. The American Psychiatric Association’s DSM approach bypasses relational aspects of women’s sexuality, which often lie at the root of sexual satisfactions and problems–e.g., desires for intimacy, wishes to please a partner, or, in some cases, wishes to avoid offending, losing, or angering a partner. The DSM takes an exclusively individual approach to sex, and assumes that if the sexual parts work, there is no problem; and if the parts don’t work, there is a problem. But many women do not define their sexual difficulties this way. The DSM’s reduction of “normal sexual function” to physiology implies, incorrectly, that one can measure and treat genital and physical difficulties without regard to the relationship in which sex occurs.

3) The levelling of differences among women. All women are not the same, and their sexual needs, satisfactions, and problems do not fit neatly into categories of desire, arousal, orgasm, or pain. Women differ in their values, approaches to sexuality, social and cultural backgrounds, and current situations, and these differences cannot be smoothed over into an identical notion of “dysfunction”–or an identical, one-size-fits-all treatment.

The website http://www.fsd-alert.org/ offers additional material on the New View campaign.

Orgasm Inc has received many favorable reviews, including one from Variety which noted: “Liz Canner’s informative, amusing, expertly crafted and well-laureled docu ‘Orgasm Inc.’ seizes the perfect platform from which to launch a common-sense attack on Big Pharma’s shameless corporatization of health, as firms try to capitalize on women’s efforts to achieve the Big O.”  For additional perspective, I might recommend a paper I authored in 2005 Is Lack of Sexual Desire a Disease? Is Testosterone the Cure?

posted by Matt Anderson

New Hampshire's Law to Restrict Data Mining by Pharmaceutical Sales

1 Comment

Rep. Cindy Rosenwald

On December 8, 2009  Representative Cindy Rosenwald, Chair of the New Hampshire House of Representatives Committee on Health, Human Services and Elderly Affairs came to Social Medicine Rounds in the Bronx.  In her talk, entitled “Eavesdropping in the Exam Room” she discussed New Hampshire’s efforts to limit data mining by pharmaceutical companies.

It was particularly nice that Representative Rosenwald was accompanied by her husband, Dr Peter T. Klementowicz, who had been a Chief Resident, Cardiology Fellow and later cardiologist at Montefiore in the 1980’s. He now practices cardiology in Nashua at Catholic Medical Center.  He made his acting debut at Social Medicine Rounds.

Eavesdroping on doctors, eavesdropping on patients

The talk began with a short skit involving a pharmaceutical rep (played by Representative Rosenwald) who attempted to convince Dr. Klementowicz that he should be prescribing more PROFITAL to his patients instead of the competition’s brand MARGINEX. The drug sales representative asked how things had been going with the free PROFITAL coupons and samples that she had left off earlier. Dr. Klementowicz seemed to defer a bit and one sensed that perhaps he had not given out any free samples. She insisted that PROFITAL had a great safety profile, while there were some concerning side effects associated with MARGINEX. The meeting ended on an inconclusive note.

Representative Rosenwald then told us that she, in her role as sales representative, actually knew at the time of the meeting exactly how much PROFITAL and MARGINEX Dr. Klementowicz was prescribing. Not only that, she already had a pretty good idea of to whom he was giving the prescriptions. Her foreknowledge of the good doctor’s prescribing habits was the result of “data mining” a process by which commercial companies acquire information on what individual doctors are prescribing.  Knowing in real-time exactly what every doctor was prescribing was, she said “the perfect marketing tool” for the pharmaceutical companies.

What kind of data was available in these databases? She began by pointing out that – at the present time – prescription databases were exempted from federal HIPAA (privacy) legislation. This is a most curious exemption and it has allowed an industry to develop selling patient data.

What kind of patient data is available for sale?  At the very least there is information about the physician and the drug. But the data might also include PLD (patient level data) that contained some “de-identified” data about individual patients and their interactions with the health care system.  This might include simply the patient’s gender, age. But, she pointed out, in a sparsely populated state like New Hampshire, knowing that a 95 year old woman in Nashua got a medication for heart failure, might identify a single individual.

One of the companies that sell such data is SDI.  Looking at their website they stateSDI actively tracks a patient’s total healthcare experience, including:

  • Filling prescriptions at a pharmacy
  • Undergoing treatment by a provider in the office setting
  • Entering a hospital or other facility for inpatient or outpatient treatment
  • Recognizing how lifestyle contributes to healthcare decisions
  • Receiving a laboratory test to evaluate disease severity
  • Detailed clinical information from electronic medical records.”

Representative Rosenwald noted that the pharmaceutical companies had additional methods to learn about individual patients.  When patients are given coupons for samples or participate in patient assistance programs, they hand their personal information over the pharmaceutical company.  This is an added bonus to the “powerful marketing tool” represented by samples and the PAP.

The Players

Data mining is not a small business.  The two largest firms are IMS Health and Verispan.  To give a sense of size, Representative Rosenwald noted that IMS Health was recently sold for $ 4 billion.

An additional player in this market is the American Medical Association (AMA), which maintains a masterfile on all MD’s and DO’s in the US. The AMA leases the Masterfile to the drug companies.   By combining data in the AMA Masterfile with the prescription data from the pharmacies, the pharmaceutical companies can create comprehensive physician prescribing profiles.  The AMA has been challenged on this policy (see the Medscape Article: AMA discloses Masterfile Physician Data to Pharmaceutical Companies). In response, the AMA set up a Physician Data Restriction Program (PDRP) in 2006.  This program allows individual doctors to “opt out” of having their data shared with individual drug salespersons.  The data, however, is still leased to the pharmaceutical companies; the AMA does not allow an opt-out for this.

Why is this system troublesome?

Representative Rosenwald noted that the current system basically allows powerful corporations to find out what is going on between individual doctors and their patients.  Beyond the privacy concerns, Representative Rosenwald raised a broader question of values.  These corporations are concerned primarily with revenue, market share and profit; this is their mandate as corporations.   Data mining provides them with a powerful, perhaps an ideal marketing tool for their ends. But as a legislator her concern, which should be the concern of clinicians, is about providing affordable, safe, high quality health care.  Data mining seems to work against those ends.by encouraging the use of expensive new medications, instead of proven and inexpensive generic ones.

What New Hampshire did:

The spark for action in New Hampshire was the ever more expensive Medicaid program.  Prescription costs were a major part of that growth and from 2001-2005, they represented an expense of about $800 per person.  The legislators reasoned that limiting access of pharmaceutical reps to physician level data might help to encourage the use of generics and bring down prescribing costs.  On May 11, 2006 they passed the Prescription Restraint Law banning the use of prescriber-identified data in sales.  This was signed into law by the Governor on June 30th and was set to into effect in July.  Under the law, pharmaceutical representatives were still allowed the use of zip-code identified data.

The law was immediately contested by Verispan and IMS; interested readers can consult their brief to the judge for their side of the controversy at this link (http://epic.org/privacy/imshealth/ims_facts.pdf).   They see the law as a restriction on their first amendment rights of freedom of speech.  Representative Rosenwald characterized their argument as being built around 3 myths: 1) that the data mining brought down costs by allowing them to target their sales efforts; 2) that it saved physicians time again by targeting company efforts to educate doctors; and 3) that it improved patient safety.  Representative Rosenwald characterized the latter argument as, perhaps, the most nefarious of all.  She pointed out that the use of databases to track errors and problems with drugs should be in the hands of a public authority and not the people selling and promoting the drugs.

The Court Case(s)

New Hampshire lost the first round of the legal battle when the law was struck down by a New Hampshire judge. At that point, New Hampshire was presented with a bill from Verispan and IMS Health for the $1.3 million in legal fees the companies had incurred. She felt that not only did this show the enormous efforts made to defeat the bill, but was also an attempt to intimidate a small state government for whom $1.3 million is an enormous sum.

New Hampshire appealed the case and the original decision was overturned in November of last year by the First Court of Appeals in Boston;  the US Supreme Court declined to hear a final appeal by the companies.  The First Court’s opinion is available at this link and includes the following:

In the pages that follow, we explain why we are not persuaded that the regulated data transfers embody restrictions on protected speech. In our view, the portions of the law at issue here regulate conduct, not speech. Unlike stereotypical commercial speech, new information is not filtered into the marketplace with the possibility of stimulating better informed consumer choices (after all, physicians already know their own prescribing histories) and the societal benefits flowing from the prohibited transactions pale in comparison to the negative externalities produced. This unusual combination of features removes the challenged portions of the statute from the proscriptions of the First Amendment.

There is a second basis for our decision. Even if the Prescription Information Law amounts to a regulation of protected speech — a proposition with which we disagree — it passes constitutional muster. In combating this novel threat to the costeffective delivery of health care, New Hampshire has acted with as much forethought and precision as the circumstances permit and the Constitution demands.

So the New Hampshire Law now stands.  This, however, is not whole story.

Subsequent to the passage of New Hampshire’s law, both Vermont and Maine passed similar types of legislation.  Vermont created an “opt in” system whereby physicians would have to choose to share their information with pharmaceutical companies.  Maine created an “opt out” program where (like the AMA program) physicians would have to chose not to participate.  Both programs were challenged in court.  A successful appeal to one these laws at the Appeals level could trigger review by the Supreme Court.

David versus Goliath

IMS Health was so upset with New Hampshire that, according to Representative Rosenwald, they stopped collecting data on New Hampshire doctors. This was entirely consistent with what was at stake.  In terms of prescription sales, states like New Hampshire, Vermont and Maine are relatively unimportant.  But they set a precedent that larger, far more (economically) important states like New York or Florida may follow. In fact, Senators Kohl and Durban introduced an amendment to the health care bill currently being debated in Congress that would impose similar restrictions.

So on the one hand we have a few courageous, publicly minded legislators for whom $1.3 million is a frightening sum.  And on the other hand we see the full force of organized medicine (ie. the AMA), the multi-billion dollar data mining industry and the multi-multi-billion dollar pharmaceutical industry.  It is really encouraging to see that so far the democratic process has worked in at least three states.  But it is also clear evidence of the fact that health care is no longer about providing “affordable, safe, high quality care” but seems more about protecting the interests of powerful corporations.

Lessons Learned

Representative Rosenwald concluded by noting some of the lessons she has learned through this process:

1. It is important to have the active help and support of your partners.  In this case, the law was supported by AARP, the New Hampshire Medical Society and the local Department of Health and Human Services.

2. Pharma and the data mining companies will fight using all the weapons they have: threats, intimidation and out spending.

Some practical steps forward.

Representative Rosenwald encouraged us to contact our Representatives to see about sponsoring a similar bill in New York.  Although she did not mention it, it might also be a good idea for physicians to use the limited AMA opt out.by logging on here.  Unfortunately, the process requires creating an AMA account. You can also call the AMA at (800) 621-8335.

And finally…

Keep up the good work New Hampshire!

Posted by Matt Anderson, MD

Is CVS price gouging cancer patients?

8 Comments

Among the most popular posts on the portal have been those in our series on Free and Low Cost Health Care.  In this post I  would like to emphasize the importance of comparison shopping for medications.  Prices for the same medication can vary dramatically from pharmacy to pharmacy.  I would like to illustrate this by sharing the story of one of my patients.

An unpleasant experience at CVS

The patient was an 80 year old woman who had just undergone her first round of chemotherapy for cancer. Her physician prescribed Ondansetron, the generic version of Zofran, an anti-nausea drug used primarily in cancer treatment.  Ondansetron is generally taken twice a day and the physician prescribed sixty 8 milligram pills in anticipation that the patient would undergo multiple rounds of chemotherapy.

When the patient went to pick up the prescription at her local CVS she was asked to pay $900. When she demurred from what seemed like an excessive price, the pharmacist offered to supply a lesser quantity of pills – 10 for $150. This was still the same price, but a lesser quantity of pills.  The patient was informed that all pricing of drugs was done centrally by CVS and that nothing could be done at the store about the price. She left the pharmacy and asked me for assistance.

I checked my Epocrates software and learned that thirty 4mg Ondansetron tablets were available on drugstore.com for about $39.99. The equivalent price for this patient’s prescription (120 4mg tablets) would be $160, not $900. To verify that this was a fair price I called a local pharmacy I use frequently in the Bronx and asked them how much they charged for sixty 8 milligram tablets.  I was told that they could sell this for $135, perhaps less if my patient did not have much money. When I mentioned the CVS price of $900 the pharmacist remarked, with a touch of irony, “that’s quite a mark-up.”

The “mark up” in this case meant that CVS charges roughly six times what other pharmacies are charging.  I would consider this to be price-gouging (“pricing much higher than is considered reasonable or fair“).  It is particularly concerning that the victim of this was a vulnerable elderly patient undergoing her first round of chemotherapy.  Fortunately, she was able to get her medicine for considerably less at a pharmacy I recommended.

CVS responds

I wrote to CVS about this case and here is the gist of their reply:

1.  CVS’s two primary drug chain competitors charge more for Ondansetron.

Learning that three of the major pharmacy chains all charge six times the going rate for Ondansetron is hardly reassuring.  And, as I never tire of repeating to my sons, “the fact that someone else gets away with doing something wrong, doesn’t mean you should do it.”

2. CVS also sells other anti-nausea medicines (notably Prochlorperazine and Promethazine) at considerably less, about $10 for a ninety day prescription.

This may well be true, but what exactly does it mean for my patient? Certainly, CVS cannot suggest that she should have exercised some type of medical judgment that Promethazine (a drug she undoubtedly never heard of) was equivalent to the medicine prescribed by her oncologist. Should she have had the oncologist paged at 6PM to request a cheaper medicine? And what if the oncologist had stated that drugs like Ondansetron  are considered among the drugs of choice for chemotherapy related vomiting? (See, for example, The Medical Letter, 12/15-29/2008)

3. Finally, CVS noted that it provided a variety of other services, such as expanded hours and online prescription ordering, that were not offered by its competitors.

Yes, but do such services justify these prices?  And will my patient be making an informed choice when she spends the extra $700 plus dollars for the CVS extras?

Let the buyer beware

The most important lesson of this story is that drug prices vary dramatically from store to store.   The chain stores are not always the cheapest. And, as many patients learn, you might have better luck bargaining with a local pharmacist.

What are the larger implications of this case?

As the debate over health care reform rages in Washington, it is important to keep in mind the fundamental question we face:  Is health care just another commodity (like bricks or toothpaste) or is it a human right?

The social argument for making health care a commodity is based on the idea that market rationality will create an efficient health care system.  Individual consumers guided by rational self-interest will make wise choices, rewarding efficient health care suppliers with their patronage and punishing inefficient health care suppliers. Of course, no actually existing health care system is run this way.  And there are many ways in which health is not like a commodity. Nonetheless, the belief that rational markets will create efficiency in health care is behind many recent reforms internationally and the current proposals to have insurance companies administer the US health care system.

But a case like that of this patient shows several of the weaknesses of this argument.  Having just received her first session of chemotherapy and without any medical expertise, this patient was particularly vulnerable and clearly  in no position to make the presumably rational choice of – for example – calling up a variety of pharmacies to ask for alternate prices.  Or of calling up her oncologist and querying her oncologist’s medical judgment.  Or of deciding that she would prefer more nausea to less money.

Indeed, can there be an economically rational choice with respect to nausea versus money?

It might be argued that the responsibility for economic rationality lies with the physician, not the patient.  But in this case the physician had prescribed a generic medication, an economically rational choice.  Is one really to expect physicians to know the prices of all the medications they prescribe at all the potential pharmacies their patients visit?

This is a dramatic case, but the issues are similar in less dramatic ones.

Wouldn’t the rational thing be for the government to assure that people get the drugs they need and negotiate real prices with the drug companies?  This solution is not without its own set of problems, but surely they are better than what happened to my patient.

A suggestion for action on this issue:

This story is old news.   In August of 2004, the (then) New York State Attorney General Elliot Spitzer released a survey of drug prices in the state and documented “Sharp Price Differences … in Common Prescription Medications.” To remediate this situation the Attorney General’s office set up a website that would allow consumers to comparison shop the 150 most common drugs: http://rx.nyhealth.gov/pdpw/Other States have undertaken similar initiatives.

And yet the price disparities continue to exist.  Perhaps this should be one of Project Censored’s top censored stories.  They take nominations at this link.

Disclaimers

The patient in this case graciously provided me with permission to share her story.  I have no financial interests in any pharmaceutical company or drug store chain.  I would not want readers of this column to construe this story as a specific endorsement of drugstore.com.  Buyers should beware, always.

posted by Matt Anderson, MD

UCSF Drug Industry Document Archive: More on Doctors and Big Pharma

5 Comments

images1The University of California at San Francisco has created a fascinating archive of documents concerning the marketing drug industry. Among them are the public records of several law suits as well as Congressional hearings.  These include suits against Parke-Davis for the marketing of gabapentin (Neurontin), against Merck for the sale of Vioxx (Cona et al vs. Merck, Humeston v. Merck & Co, Hermans et. al v. Merck & Co., Ernst et. al. v. Merck & Co) as well as the Grassy and Waxman Congressional Hearings.  The site contains links to external documents (press reports, academic articles, government documents) which provide further context.

Among the many fascinating documents is a list of physicians that Merck sought to “neutralize/discredit” because they were not favorable enough to Vioxx.  Some of these names come with an ominous all-caps and bolded “NEUTRALIZED” under their names.  Each physician has noted down their contact information, affiliations, a detailed description of why they are problematic, and a recommended plan of action.

Dr. John J. Condemi, a speaker for Searle (a Merck competitor) was someone targeted for neutralization. According to the documents Dr. Condemi had the following background: “Thought leader in the community and Upstate NY; speaking on behalf of Searle as an advocate and investigator; recently enrolled him in a clinical trial (RA) after many months of promises and hard effort; not entirely certain this wasn’t too little, too late; speaking to community physicians at programs sponsored by Rochester Blue Cross Blue Shield (80% market share in a 90% managed care market); have not been in attendance at these meetings, but can imagine that VIOXX has not been mentioned nearly as often as Celebrex; has trained many of the RHU in the Upstate area and is considered the expert by many (thus, the reason BC/BS has used him as a speaker); has done studies on FOSAMAX and SINGULAIR but for some reason was slighted by us for VIOXX; wants to be involved with VIOXX.” As this document shows one of the ways to win physicians is to enroll them in “clinical trials.”

The plan for Dr. Condemi is as follows: “Provide scientific information; research; interested in NSAID-induced asthma; provide investigator slides to balance presentations; personal visit by a “heavyweight” from MRL or CDP (Greg Bell or Greg Geba) to discuss where we want to go with VIOXX; could work with him to develop a clinical pathway for COX-2 inhibitors in a managed care setting; panel with Dr. Singh of Stanford and some others to focus on pharmacoeconomic studies which verify reductions in PPI or H2 blocker use.  – He is in a clinical trial; – He is attending a program given by Dr. Geba  – Speaker – doing a good job

Dr. Max Hamburger, President of a large, private Rheumatology practice in Long Island (New York) is listed as having become an ADVOCATE. Here the hook was not a clinical trial but rather financial support.  Hamburger’s practice was important to Merck because it included “high volume prescribers” who were users of Celebrex (an anti-inflammatory drug that competed with Vioxx).  Here is how Merck characterized the situation presented by the practice: “companies that provide funding will receive preferred status with its members and those that do not will have trouble accessing the IPA members; first endeavor is to put together a “Standards of Care” retreat meeting to develop a document that will serve as their manifesto (to include a drug formulary and how the members will treat certain diseases, preferred medications); price tag is $25,000 to support this meeting and to have access during it.” In its recommendation the document concludes: “Financial support of private practice rheumatology IPA – (has taken place). Has been turned around.” Such horse-trading is worthy of a grade B movie.  It is important to remember that we are talking about highly expensive and dangerous medicines.  And patients who trusted their physicians to provide the best-possible clinical advice, not suggestions based on which drug company was willing to finance their practice.

This types of relationships form part of the context for a recent JAMA article recommending that professional medical associations sharply curtail their reliance on drug companies for financing (Rothman et. al. Professional Medical Associations and Their Relationships With Industry: A Proposal for Controlling Conflict of Interest, JAMA 2009;301:1367).  The document offers a number of specific recommendations and concludes: “PMAs should work toward a goal of $0 contributions from industry; they should not collaborate in or profit from industry marketing activities; PMA leaders and executive staff should be free of conflict of interest and, in time, so should the entirety of the board and the members of the practice guideline committees.”  Since so many of the “leaders” in organized and academic medicine have close financial ties to industry, this is essentially a call for revolution.

How much such a revolution come about?  It would seem to us that the only way would be in the context of a universal, publicly funded and administered health care system which is measured by its ability of efficiently protect and promote the health of the populace.   Is that a revolutionary idea?

posted by Matt Anderson, MD

No More Drug Company Pens: A Trojan Horse?

13 Comments
I fear the Greeks...

I fear the Greeks...

As of January 1, 2009 drug company sales representatives are no longer supposed to be distributing branded trinkets such as pens and pads to doctors.  Hearing of this, I could not help thinking of the Trojan priest Laocoon. During the Trojan War Laocoon was rightfully suspicious of a certain wooden horse left by the Greeks on the beach.  “I fear the Greeks even when they bring gifts,” he is quoted by Vergil as saying.  Unfortunately, for his audacity (and for throwing a spear into the side of the Trojan Horse) he was punished by Minerva, protectress of the Greeks.  She sent two sea serpents who, after eating Laocon’s two children, proceeded to devour him.  I guess this illustrates the dangers of speaking truth to power.

The new rules are reflected in a revised Code on Interactions with Healthcare Professionals adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA).  These regulations had been adopted in 2008, but did not go into effect until January 1.  They cover a variety of ways in which pharmaceutical representatives can interact with physicians.  For example while pharmaceutical representatives can provide meals if they are making a presentation, they can no longer: “provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company.”

With respect to branded trinkets the rules state:

Providing items for healthcare professionals’ use that do not advance disease or treatment education — even if they are practice-related items of  minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to healthcare professionals or members of their staff, even if they are accompanied by patient or physician educational materials.

Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs or tickets to a sporting event) likewise should not be offered.

Payments in cash or cash equivalents (such as gift certificates) should not be offered to healthcare professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest.

It seems a big disingenous to think that providing branded mugs fosters just the “misperception” that interactions are not based strictly on the science.  In fact, the very description of what is prohibited is a laundry of the unsavory types of interactions that have long characterized the work of drug reps.  (See our previous posting Former Pharmaceutical Reps Tell All).  The PharmedOut website has some interesting new videos in which drug reps discuss how they ply their trade.

So, is this really a “gift” from Big Pharma? Or a Trojan Horse?  Or a bit of both?  Here are some comments we have received as we have asked our colleagues what they think of these new rules.

1. This is big.

Activist groups, such as No Free Lunch, the National Physicians Alliance and Healthy Skepticism, have long wanted to see branded trinkets out of doctors’ offices.   This has been reflected in efforts such as No Free Lunch’s Pen Amnesty and NPA’s Unbranded Doctor campaign.  It really is quite meaningful that doctors are no longer allow their bodies and their workspaces to serve as barkers for the drug companies.  This is big in that sense.

2. This is a small drop in a big bucket leaving the drug companies with many other ways to influence phyiscians and patients.

To put this change in context,  it is useful to reflect on the overall size of drug promotion to physicians.   According to a 2008 article by  Marc-André Gagnon and Joel Lexchin in PLOS: Pharmaceutical promotion in the United States in 2004 is as high as $57.5 billion compared to the figure of $27.7 billion given by IMS. Excluding direct-to-consumers advertising and promotion towards pharmacists, the industry spent around $61,000 in promotion per practicing physician.”

Well, $61K per doctor clearly is not buying trinkets.  What kinds of things are not covered by this exclusion?

1. The industry is still a major player in continuing medical education for physicians.  The role of big Pharma in CME was the subject of the August 30, 2008 British Medical Journal which reports that half of all CME is sponsored by pharmaceutical and medical device companies (see Roy Moynihan’s article:  Is the relationship between pharma and medical education on the rocks?

2. The industry will still be allowed to give free samples for patients. [It would, of course, be so  much nicer if they just took the $57.5 billion spent on advertising and lowered their prices.]

3. The industry can still produce patient education materials and pursue direct-to-consumer advertising.  It is not clear if infomercials, like the dreadful CNN Accent Health (hosted by our future Surgeon-General Dr. Sanjay Gupta) will continue to be allowed.

4. Drug representatives will continue to be allowed to give “informational presentations” to physicians along with free lunches.

5. The drug company can still hire physician “experts” to serve as paid consultants and speakers.  Members of committees which set drug formularies can be speakers and consultants as long as they disclose this to the drug company.

6. And drug companies can continue to gain access to the prescription history of individual physicians.  This may be the Trojan Horse in this gift.

4. These voluntary limits may be intended to forestall legislation with a far wider impact.

Current practice allows the pharmaceutical companies to purchase information on drugs prescribed by individual doctors. This is done without the consent of the physician or the physician’s patients.  The American Medical Association colludes with this policy by selling its Masterfile of physicians to the drug companies.  Sales of the Masterfile amounted to $44.5 million in income for the AMA in 2005.  (This information is drawn from an NPA issue brief).  This arrangement has been described as making the drug company “a silent third party in the examining room.”  Actually it’s more like the fourth party, because the insurance company also seems to be watching over every encounter.  Further background can be found at the NPA site.

New Hampshire, Vermont and Maine have all banned the sale of such data to the pharmaceutical companies, see a posting by the Electronic Privacy Information Center.  And a similar campaign is underway currently here in New York State.

In addition there are a number of laws on the books or proposed that would require physicians to make public any gifts or payments by drug companies.  Impetus for these laws came from 2007 and 2008 hearings held by Iowa Senator Charles Grassey of the Special Committee on Aging.

Given all these threats, Big Pharma may have decided it was better to get rid of the trinkets.

5. Why didn’t this come from the doctors?

The drug companies are facing an increasingly hostile and critical international movement.  Many of the most active members of this movement are physicians.  But they seem a minority within medicine.  The bulk of physicians seemed content to take trinkets.  There was no mass movement of physicians to “unbrand.”  And the AMA has been resistant to discontinuing its role in data-mining.

Whose side are we on anyway?

posted by Matt Anderson, MD

Trade & Health at 2008 American Public Health Association Meeting

1 Comment

Click above to see the video

In November we posted presentations by the Spirit of 1848 caucus at the 2008 American Public Health Association annual meeting.  We also felt it was important to share some of the presentations on trade and health that have been posted by the Center for Policy Analysis on Trade and Health, CPATH.  These represent cutting edge work on how trade agreements are impacting upon health.

Here is a listing of presentations, most with links to the actual slides or posters. You can also download them from the CPATH website.

Health & Trade Policy for Specific Industries. Moderator: Garrett Brown

Public Health Strategies to Address Trade Policy. Moderator: Kristen D. Smith

Trade Policy, Health, Economics & Justice Moderator: Susanna Rankin Bohme

Influence of Trade Policy on Health: Poster Session

To obtain copies of the following presentations, you should contact the authors:

  • Cross-border hazard and cross-border justice: The Case of DBCP. Susanna Rankin Bohme
  • FTAs and public health in Chile: The need for a policy research agenda. Leonel Valdivia
  • Trade and nutrition: Consequences of free trade agreements in Peru, Chile, and Mexico. Sural Kiran Shah
  • Corporate social responsibility: What is it good for? Beth Rosenberg
  • Economic Liberalization and the Postcommunist Mortality Crisis. David Stuckler
  • CAFTA and the Global Campaign for High Drug Prices. Ellen R. Shaffer

posted by Matt Anderson

Free & Low Cost Medicines

1 Comment
Herceptin costs $3,000 a month

Herceptin costs $3,000 a month

As part of our series on free and low cost health care in New York I wanted to share a few resources on free and low cost medicines.

Dr.  Brian Alper (a family physician who founded DYNAMED) has put together a very useful set of clinical links for physicians at: www.myhq.com/public/a/l/alper. Among the many categories in this list are six links to “indigent drug programs.”   To test these sites out, I decided to look up Herceptin, an anti-cancer agent made by Genentech.  [I was recently asked to find this drug for a medically indigent patient.]

Needy Meds: is a not-for profit “with the mission of helping people who cannot afford medicine or health care costs.” The information at NeedyMeds is available anonymously and free of charge.  The most useful part of this website is the listing of drugs – both generics and brand – that are available from patient assistance programs (PAP’s).   If you find a drug and a PAP, many of the applications can be downloaded from the website.  Most of the links seem to be from 2008.  The site also has a link to free clinics.   I easily found Herceptin on the Needy Meds site with links to application form in English and Spanish as well as the Genentech website.

Rx Assist is managed by Astra Zeneca and claims to be the “Web’s most current and comprehensive directory of Patient Assistance Programs.”   The Rx Assist site has a searchable database so you don’t have to scroll down lists.  Herceptin was also easy to find on RxAssist, but the site linked only to the English application and the Genentech site.

Benefits CheckUp is run by the National Council on Aging and is a very different type of site.  It provides information on a wide variety of benefits – housing,  food, medication, medical care, utilities, “and more.”   It works a little bit like an online social worker.  To find information on Herceptin (for a fictious patient), I needed to input zip code, age, information about work, income, and assets; this process generally takes 10-15 minutes according to the website.  I could easily imagine that it would take much longer if you had to find all the documentation.  When this was through, Benefits CheckUp suggested I apply for New York State’s EPIC program (which helps elderly people with prescription costs), New York State Medicaid and also offered the Genentech program.  There were links to the Genentech site, application forms, and even a list of documents I would need.  Very complete, but a bit daunting in terms of the information I needed to supply.

All three of the above sites linked to a variety of health care resources, not just medications.

Partnership for Prescription Assistance also links to PAP programs.  This site required me to enter information (age, location, income, insurance coverage, etc) before leading me to the Genentech site.  It did not link directly to the Herceptin application. Unlike the sites listed above PPARx did not provide links to other types of social programs (such as free clinics).

Finally, Dr. Alper’s site links to an August 2004 article in the American Family Physician “Curbside Consultation:  When Patients Cannot Afford Their Medications” This is a very thorough review of the topic with – in typical AFP style – lots of useful information. According to the AFP article 5.5 million people were enrolled in PAP programs in 2002.

I would note that – based on my personal experience – the typical patient who needs the PAP’s often times does not have access to the internet nor facility with completing forms.  So having someone to be their advocate is crucial.  This is a weakness of these websites.

A couple of additional suggestions:

Patients should always check to see if they are overpaying.  Do this by looking up the prices of medicines on Drugstore.com.  Oftentimes pharmacies charge unreasonable prices (people go, after all, to the local store) and lots of money can be saved by shopping around.

A recent blog from Suite 101.com entitled “How to Find Free, Cheap Drugs” offered (among other information) a list of retailers offering low cost or free medications.   These include WalMart, Target, K-Mart, and various food chains.  For example, “Publix supermarkets offer free antibiotics if you have a valid prescription, regardless of whether you have health insurance.  A 14-day supply is offered.”

Some sites I have seen offer to help patients find low-cost drugs from a small fee.  Clearly this is not reasonable since this information is available for free.

As I have noted in previous blogs these various efforts do not solve the root cause of the problem: lack of universal access to healthcare (including medications) in the United States.  But for patients in need these resources can be helpful.

Posted by Matt Anderson, MD

National Physicians Alliance "Unbranded Doctor" Campaign

Add a comment

In our last posting we discussed the visit of Dr. Jean Silver-Isenstadt of the National Physicians Alliance.  In this posting we will focus more closely on the NPA “Unbranded Doctor Campaign” part of an attempt to protect integrity and trust in medicine. This campaign asks doctors to stop accepting gifts, however small, from pharmaceutical companies.

The campaign offers resources on how to become an unbranded doctor. Among these is a slideshow from the Madras Medical Group documenting their transition from accepting visits and gifts from pharm reps to becoming “Pharm-free.”  Not as easy as it sounds, particularly since not everyone felt this was a good thing initially.  There are links to videos, including the Frontline Expose A Bitter Pill which discusses the problems with the FDA’s role as watchdog of medication safety in the US.  There is a reading room of both books and articles.  And finally there is a listing of “sources of independent medical information and industry-free CME.

The campaign is being conducted in association with the American Medical Student Association, No Free Lunch, and Pharmed Out.  The website links to several blogs: PostScript, The Carlat Psychiatry Blog, Hooked: Ethics, Medicine, and Pharma, GoozNews, and Pharmalot.

This initiative is also associated with the Prescription Project, an effort “led by Community Catalyst in partnership with the Institute on Medicine as a Profession.  Funded by the Pew Charitable Trusts, the Project seeks to eliminate conflicts of interest created by industry marketing by promoting policy change among academic medical centers, professional medical societies and public and private payers.” The specific platform supported by the Prescription Project are the recommendations published in the January 2006 JAMA.

The Unbranded Doctor campaign is closely associated with several other NPA initiatives.  The Protecting Prescription Privacy Campaign seeks to bar pharmaceutical companies from purchasing prescribing information about individual doctors. This information is used to target Pharma advertising.  They are also supporting S. 2029 The Physician Payments Sunshine Act which seeks to force reporting of pharmaceutical gifts to doctors.

Last, but not least, you can actually buy “Unbranded Doctor” paraphernalia including mugs, T-shirts and wall clocks.  Who would have thought?

Commentary

It is heartening to see the range and depth of activism around this issue, which even involves important elements within “mainstream” academic medicine.  However, it is worth remembering that according to a 2008 article by  Marc-André Gagnon and Joel Lexchin in PLOS: Pharmaceutical promotion in the United States in 2004 is as high as $57.5 billion compared to the figure of $27.7 billion given by IMS. Excluding direct-to-consumers advertising and promotion towards pharmacists, the industry spent around $61,000 in promotion per practicing physician.”

$61K per doctor! This is truly a Goliath.

Posted by Matt Anderson




Open