Policy and Medicine

Physician Payment Sunshine: Media Support Equals More Stories

Continued media coverage of the sunshine provisions in the Senate and House health care reform bills continued today as the New York Times reported that such efforts may not be enough.  (They want more stories)

 

The sunshine provisions require the makers of drugs, medical devices and medical supplies to file annual reports to the government about their financial ties to doctors.

The legislation would also require the establishment of an online public database that patients could search, to see if their own physicians had been paid by the companies whose products the doctors prescribed.

Extreme radical pharmascolds believe this kind of disclosure and reporting is not comprehensive enough because there have already been instances “of doctors who, despite strict disclosure policies by their academic employers or the National Institutes of Health, failed to report payments from industry.” As we have covered such cases numerous times, the overwhelming majorities of such errors were never intentional, and were mostly due to confusion on the requirements by various journals and institution policies.

Internist and Stem Cell Ethicists Dr. Bernard Lo at University of California, San Francisco, who served as chairman of the IOM committee on Conflicts of Interest in Medical Research Education and Practice essentially called on “Congress to mandate industry disclosure of payments to all kinds of health care providers, medical researchers, medical institutions, professional medical associations, industry-sponsored foundations and disease advocacy groups.”

As the provisions in the Senate stand right now public disclosure of industry payments would be required to doctors and teaching hospitals, as well as ownership stakes in medical facilities and medical products companies. Groups not presently required to disclose include people like nurses and biomedical researchers or groups like professional medical associations.

Consequently, such a gap leaves open the possibility that Senator Charles Grassley (R-IA), a co-creator of the sunshine provision according to his spokeswoman is open to “expand the payment disclosure requirements to other medical players,”

According to the NYT article, “the health overhaul effort in the House goes further, calling for public disclosure of industry payments to a wide array of medical entities and medical professionals — a group as diverse as physicians, pharmacists, biomedical researchers, professional medical associations and health insurers.”

Proponents of such disclosure requirements believe that since these entities “are making determinations as to what procedures and drugs will be used,” sunshine provisions cannot leave any loopholes. For example, Representative Pete Stark (D-CA) believes that companies could give rebates to outpatient clinics to favor certain medical products over others, a scenario he uses to call for stronger measures.

In response to sunshine provisions, the Pharmaceutical Research and Manufacturers of America (PhRMA) told NYT “that any federal legislation requiring payment disclosures must be written in a way that did not imply that industry relationships with health care providers were automatically inappropriate.” Others who are skeptical of disclosure address the need for a federal database to use that would offer more detailed information than the few doctor payment listings now available to the public.

States like Minnesota and Vermont already require drug companies to report payments to physicians, and drug companies like Eli Lilly and Merck have introduced their own Web sites listing fees paid to doctors as we have previously written.

Eli Lilly and Sunshine – More Stories for Papers

Since Eli Lilly started reporting payments the first half of this year, they have paid 3,971 doctors and other medical professionals an average of about $11,230 each. The payments were for participating in an average of 12 speaking or consulting engagements during those six months, according to a company spokeswoman.

A separate NYT article focused on payments from Eli Lilly to Dr. Manoj V. Waikar, a psychiatrist in Palo Alto, Calif., who is also an adjunct clinical instructor in the department of psychiatry and behavioral sciences at the Stanford University School of Medicine. So far he has received $74,850 for consulting and speaking at 51 events. The company caps payments at $75,000 for each health care provider in any calendar year. As a result of just $1,500 per event, the article tried to determine why Dr. Waikar received such payments.

Dr. Waikar wrote in an e-mail message to NYT that he received fees for speaking to other health care professionals about disorders like schizophrenia and depression, which can be treated with the Lilly drugs Zyprexa and Cymbalta respectively. Having spoken so many times about the treatment of such diseases that affect millions should not be underscored by payments he received for such services, when doing so is not only legal, but essential for improving patient care.

In addition, Dr. Waikar’s speaking need not be overly scrutinized because Stanford only prohibits full faculty members from participating in drug company speakers’ bureaus. Dr. Waikar, who is an unpaid adjunct instructor, was allowed to engage in these critical educational events because he did not use his Stanford title, as the school’s policy requires.

Stanford announced they are reviewing the policy for adjunct professors, which is not surprising given that Philip A. Pizzo, MD The Dean of the Stanford Medical serves on the board of the anti industry group Prescription Project (which the Prescription Project has since taken down the board names from their website – so much transparency for these guys).

Not only was Dr. Waikar following Stanford’s rules explicitly, he even indicated in his email to reporters that not only were the “drug company presentations standardized to comply with drug marketing regulations, he and other speakers provided suggestions on the content.” Moreover, Dr. Waikar acknowledged that he was even able “to answer questions from doctors in the audience, drawing from his own practice experience or opinions, as long as he explained the basis of his answers.” Evidence of such “spontaneity” only goes to show how unbiased his work truly was.

As a result of his service, Dr. Waikar has been contacted by many doctors after his talks to consult about difficult cases, especially from primary care providers who have to treat complex psychiatric problems. Having this ability to reach out to him could not have been possible if it were not for the support of such talks by Eli Lilly.

Misinterpretation of Disclosure

The work of Dr. Waikar should ring loud for proponents of more disclosure like Dr. Lo, who still maintain that drug companies control the content of such speeches. If there continues to be a push for more disclosure, as others have indicated, the government will only begin to use this information against doctors, which will in the end only hurt patients.

One anti industry pundit stated about this case and working with industry in general:  “If you can live with public exposure of your accepting gifts and fees from the pharmaceutical and medical device and imaging industries, then go for it. But in a few years, this information will all be known, not just to you and the few people attending your seminars, but to your patients, to your employers and to the government."  Look out they want to sick the government on physicians working to educate other physicians (ouch)

The problem with reports like the IOM report is that “disclosure requirements often omit information that could help clarify the relationship between physicians and the treatments the doctors prescribe.” This statement is from Lisa A. Bero, a professor of health policy at the medical school of the University of California, San Francisco. In other words, the problem is not always the doctors failing to report.

Regardless of Dr. Lo’s recommendations, even as the New York Times admits, the IOM report itself indicated that “the public could benefit when doctors and researchers collaborated with the industry to develop new and effective products.” Since the report makes such an acknowledgement of the value of researcher-industry collaboration, present disclosure policies are more than enough for the public to judge whether such relationships exerted too much influence on patient care.

In the end newpapers will sell more stories of physicians and others working with industry if they can expand the people covered.  Americans love to hear specifics about others income, we love controversy.

JAMA: HPV and Cervical Cancer Treatment Gardasil - Choosing to Ignore the Facts

Cervical Cancer is a serious disease and the second leading cause of cancer death in women world wide.  In the US it is treatable.  The American Cancer Society estimates that in 2009, about 11,270 cases of invasive cervical cancer will be diagnosed in the United States. Some researchers estimate that non-invasive cervical cancer (carcinoma in situ) is about 4 times more common than invasive cervical cancer.

Cervical cancer occurs most often in Hispanic women; the rate is over twice that in non-Hispanic white women. African-American women develop this cancer about 50% more often than non-Hispanic white women.

But cervical cancer which is caused by a sexually transmitted virus (HPV) is now largely preventable with the vaccine Gardisil developed by Merck.

 

In this weeks, JAMA there are two articles on Gardisil the first titled: Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine  is authored by physicians and researchers from the US Centers for Disease Control and Prevention and the Food and Drug Administration  that research article points out that Gardisil is safe and effective in preventing HPV.

 

“We feel confident recommending people get the vaccine; the benefits still outweigh the risks,” “This is the most complete picture we have.” said Dr. Barbara A. Slade, the study’s first author and medical officer with the Centers for Disease Control and Prevention.

 

But ignoring evidence even from the CDC and the FDA Catherine De Angelis, MD Editor and Chief of JAMA issued another “Special Communications”  (special communications is JAMA code for anything the editor wants it to be selected by the editor bypassing traditional channels, lately focused on anti industry articles) this time taking a blow at Gardasil, Merck’s new vaccine against 4 types of human papillomavirus (HPV). 

 

The recent Shelia and David Rothman, PhD (sociologists, not cancer researchers with the Institute of Medicine as a Profession) Special Communication in JAMA published suggests that there are “critical and unresolved questions ... [concerning the] manufacturer’s decision to market its HPV vaccine primarily as an anticancer vaccine.” JAMA authors then asked the following:

 

 

· Is the vaccine being targeted to adolescents at greatest risk and who stand to benefit?

· Do professional medical associations (PMAs) that received funding from the company provide members with unbiased educational materials and balanced recommendations?

· Did the PMAs ensure that marketing strategies did not compromise clinical recommendations?

· Was the design and implementation of vaccine policy for adolescents consistent with scientific knowledge?

 

Interestingly, JAMA itself acknowledges that “the new vaccine against 4 types of HPV … appears to be a cost-effective intervention with the potential to enhance both adolescent health and the quality of their adult lives.” So the problem does not appear to be with the science of the medicine, rather “the messages and the methods by which the vaccine was marketed.”

 

In other words, JAMA believes that the means (the development of an HPV vaccine) used to accomplish the end (Gardisil), are somehow “unethical” because industry was involved. Regardless of the fact that without industry this “cost-effective intervention…that will enhance adolescent health and quality of their adult lives” would not exist, JAMA continued to discredit the manufacturers.

 

JAMA further claimed that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the subpopulations most at risk practically ignored.” Another claim by JAMA is that the vaccine manufacturer which provided educational grants to (PMAs) “did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on risks and benefits.”

 

JAMA goes on to further describe that Gardasil was “promoted primarily to “guard” not against HPV viruses or sexually transmitted diseases but against cervical cancer.” The article somehow tries to correlate this promotion with enabling “its manufacturer to circumvent possible parental and public unease with an antidote to sexually transmitted diseases.” The drug was approved by the FDA, and went through all the clinical trials and research necessary, what more do parents need?

 

Continuing through the article, the authors assert that Merck only concentrated on “populations in geographic areas with excess cervical cancer mortality, including African Americans in the South, Latinos along the Texas-Mexico border, and whites in Appalachia.” According to JAMA, Merck did this so they could market to consumers “that every girl was at equal risk” and that “Your daughter could become 1 less life affected by cervical cancer.”

 

PMA’s

 

In order to further the goal of treating patients and finding effective treatments for cervical cancer, Merck funded established Professional Medical Associations (PMAs)  such as the American Society for Colposcopy and Cervical Pathology (ASCCP).

Instead of looking at these educational grants neutrally for what they provided to research and academia, JAMA asserted that the American Society for Colposcopy and Cervical Pathology (ASCCP) “perceived the vaccine promotion as an opportunity to turn a potential financial liability into an asset.”

 

Somehow JAMA interpreted ASCCP’s prediction about the need for new practitioners to educate about HPV and cervical disease as a risk. Moreover, the educational grants allowed the ASCCP to create an “Educate the Educators” program, training members to promote vaccine use, especially in “smaller and mid-sized communities that lack clinicians who have expertise in this area.” What is so unethical and wrong with that?  Is this not what CME is supposed to do meet the unmet needs of communities?    I would venture to say that these programs would receive commendation for such targeted actions, reaching physicians and patients with the greatest need.

 

In fact, the ASCCP also “arranged opportunities for CME accredited courses through “grand rounds, in-service opportunities, patient education forums, risk management and quality improvement meetings, and professional association society meetings.” With statistics like “worldwide, cervical cancer as the fifth leading cause of cancer death in women, 473,000 cases of cervical cancer, and 253,500 deaths per year” why would

JAMA even try to question such a breakthrough?

 

ASCCP materials also advocate for physicians to help in “convincing states and federal agencies to pay for the vaccine, convincing insurance to pay for it [and] encouraging state mandates for use.” What else more could JAMA want in order to help patients with an effective treatment?

 

Surprisingly, JAMA did get one thing right in this article: “Professional medical associations are obligated to provide members with evidence-based data so they can present relevant risks and benefits to their patients.” That is exactly what Merck and the CME providers they support have done, and continue to do.

 

About the Authors

 

One colleague noted that it is almost impossible for the article in JAMA to have been peer reviewed prior to publication, because the bias was so pervasive throughout the commentaries (they tried to make it to look like research but in reality it was nothing but pure commentary).

 

This article is pure David Rothman, PhD Director of Columbia University’s - Institute of Medicine as a Profession, who has received closed to $10 million  from George Soros and his Open Society Institute  to discredit the pharmaceutical and device industry, he is the lead author of this past springs JAMA published paper calling for an end of all relationships between industry and Professional Medical Associations (PMA’s). 

 

In addition, David is the founder of the Prescription Project whose total goal is the same to eliminate “conflicts of Interest” code for all interest and relationships between industry and healthcare providers.  He lives in a world were all drugs and devices are for the betterment of man and should be given away free of charge.

 

Fortunately the press did not follow the religious zealot line that Rothman portrayed and focused on the benefit that young women receive from getting the vaccine.   This even includes the NY Times plus a plethora of other news papers.  (Sorry but science sells and propaganda does not)  But you keep ignoring the truth David, you must or your funding will dry up.

 

ASCCP Response

 

In response to the article, ASCCP issued a press release asserting that their “mission of ASCCP is to improve clinician competence and patient outcomes through provider education.” As a result, the organization endeavored into the research of an HPV vaccine because of the “widespread ignorance about HPV and its role in cervical oncogenesis.” Therefore, ASCCP wanted to educate clinicians about HPV vaccines, and in order to do so effectively and efficiently, accepted funds from a variety of sources, including HPV vaccine manufacturers.

 

The reason ASCCP accepted such funds from industry is because “funding for this purpose has not been available through government or nonprofit sources.” How else does JAMA expect physicians to cure the world’s second highest killing disease for women?

 

Specifically, ASCCP noted that although “the current prevention system based on Pap testing, colposcopy and destruction of precursors is effective, it remains expensive, intrusive, insensitive and nonspecific.” Moreover, they noted that “because it cannot be determined which women with CIN are fated to develop cancer, it results in overtreatment of thousands of women each year, with consequent cost, procedure-related injury, and perinatal morbidity resulting from cervical compromise.” That is why ASCCP accepted funds to develop a more effective treatment, and why “industry representatives played no role in the development or content of ASCCP educational materials.”

 

ASCCP also wrote a asserting the following points:

• The Food and Drug Administration (FDA) has approved HPV vaccination as safe and effective, reflecting the opinion of cervical cancer experts—which Rothman and Rothman are not—that vaccination will decrease the burden, not only of cervical cancer, but also of precancer, with fewer abnormal Pap tests, colposcopies, and cervical treatments.

• Materials were peer reviewed and financial support disclosed.

• While the authors argued that ASCCP failed to emphasize vaccination of high-risk populations, some 80% of sexually active women will acquire HPV, though most clear infection, so all women are at risk. Cervical cancer rates are highest in unscreened women. ASCCP has supported efforts to protect these women, including education of clinicians who serve them, collaboration with government agencies, and primary prevention through HPV vaccination.

• ASCCP supports a dialogue to advance efforts to provide vaccine to low income, immigrant, and minority women at greatest risk. Some controversial aspects of vaccination, including “catch-up” vaccination for sexually experienced women, were evaluated and approved by the FDA and subsequently adopted by the Advisory Committee on Immunization Practices (ACIP); ASCCP reported and explained ACIP positions in its educational materials but did not influence their adoption.

• ASCCP will continue to use income from a variety of sources including industry to support our mission of improving the lives of women through education about HPV, conventional screening and treatment, and HPV vaccination.

  

In the end, ASCCP put it best: “it is unethical to deny a generation of women access to HPV vaccination while waiting to demonstrate a decline in cervical cancer rates.” We should praise these entities for their breakthroughs with industry, and Americans should all appreciate the lives they will save.

 

If you have a choice who do you believe anti industry zealots David and Shelia Rothman or the researchers at the FDA and CDC?  My money goes on the CDC and FDA, I would encourage everyone else to do the same and get your daughters vaccinated.  I certainly will.

 

Thomas Sullivan, Author of Policy and Medicine is the President of Rockpointe

In 2005 – 2006 Rockpointe/Potomac Center for Medical Education produced CME activities on HPV and Cervical Cancer supported by Merck US Human Health.   We are confident our efforts have contributed to lives saved by educating health professionals on preventing cervical cancer in women. 

 

 

Pharmascolds an Official Term

Pharmascolds has been added to the American vocabulary this week according to Schott’s Vocabulary column in the New York Times.

Definition:  Those critical of the relationship between (the pharmaceutical) industry and academic medical research. (Pharmaceutical + scolds).

So from now on, critics of industry, the Angell-Relman’s, DeAngelis, the Prescription Project, the Institute of Medicine - as a Profession, the Macy Foundation, and the small group of academics they influence, now can all be defined as Pharmascolds.

Institute of Medicine as a Profession: Next Stop Patient Advocacy Groups

Last week, the Institute of Medicine, as a profession, launched an attack on medical societies in The Journal of American Medical Association (JAMA) entitled, “Special Communication” Professional Medical Associations and Their Relationships with Industry a Proposal for Controlling Conflicts of Interest.

The report was planned for several years and paid for by Pew Charitable Trust monies through the Prescription Project to Institute of Medicine as a Profession: IMAP-Prescription Project: Report on Conflict of Interest in Medical Societies  (December of 08 Post).

According to Merrill Goozner:  During a conference call, three of the eleven co-authors on the paper predicted many major medical societies will seriously consider the proposal.

"Ten years ago (concerns about conflicts of interest) was a breeze, five years ago a wind, now it is a gale storm," Rothman said.  "Change is going to come.  The likelihood of these recommendations being implemented is quite strong."

Only two current leaders at professional societies -- Ralph W. Hale of the American College of Obstetricians and Gynecologists and James H. Scully of the American Psychiatric Association (APA) -- were among the 11 signers.  Last week, the APA made news by declaring it would stop taking money from industry.

Goozner also notes:  The next target on IMAP's radar screen: patient advocacy groups, many of which receive all or nearly all of their funding from the drug, biotechnology, or medical device companies.  "We are going to address these patient advocacy groups, some of which are grass roots and some of which are astro-turf," Rothman said.

Patient advocacy groups need to be alerted that this very effective strategy as seen with Academic Medical Centers (Brennan paper 2006, followed by AAMC Taskforce 2008, followed by major reforms 2009), and now Medical Specialty Societies is a model that is working for IMAP.  This will be used against them.

They want to cause shame for doing the right thing (working with industry to develop new products that saves lives) even if it costs more in the short run. 

This strategy should be exposed for what it really is, short sighted contempt.  Medical societies, academic medical centers, and patient groups need to stand-up against this bullying tactic; otherwise as a society we will all suffer the consequences of a lost medical research and education base.

Prescription Project Conference: Drug Free Zones

Finally, the White House and the U. S.Capitol Building have become “drug-free” zones from the corrosive and corrupting influence of lobbyists for the pharmaceutical and medical device industries.  State Senator Richard Moore, MA

This was the undercurrent of the recent conference of the Prescription Project held last month in Washington DC.

Presentations included “Reform of the Food and Drug Administration (FDA),” by Bruce Psaty, M.D. and Steven Nissen, M.D., both unofficial candidates for the job of FDA Commissioner, and “Incentivizing Drug Discovery and Drug Safety,” by Alastair Wood, M.D.  These presentations are actually quite balanced.

Barbara Barnes, M.D., of the University of Pittsburg and Chairman of Accreditation Council for Continuing Medical Education (ACCME) Board of Directors, gave a presentation on “Interactions between Industry and Academic Medical Centers: Managing the Boundaries.”

They also included their typical list of industry bashers, including Daniel Carlat, M.D., whose presentation was “Industry Funding of continuing medical education (CME): How Drug Companies Have Taken Over Medical Education,” (I am not certain what year he is living in, but it is certainly not 2008 or 2009). 

Remarks by Henry Waxman, the newly elected Chairman of the House Energy and Commerce Committee, gave some insight on the direction he will be taking.

State Senator Richard Moore, of Massachusetts, the Chairman of the Joint Committee on Healthcare Financing titled his presentation “Never Trust the Lamb to the Custody of the Wolf” (this one is worth looking at, because he will be sitting in as Chairman of any additional industry bills that Massachusetts may want to pass this year.

Overall this was an interesting conference and worth downloading many of the remarks and presentations. 

Full presentations, remarks, a list of organizations that attended, and agendas are available online at the Prescription Project Website.

IMAP-Prescription Project: Report on Conflict of Interest in Medical Societies

Prescription Project who’s stated goal is Ensuring that industry-physician relationships are free of conflicts of interest …(kicking industry out of medicine), has hired The Institute of Medicine as a Profession to write a report on Conflict of Interest Policies in Medical Societies is expected to be released in Early 2009.

According to both parties the Report will be very similar to the AAMC report on conflict of interest in medical education released earlier this summer but without any of the constraints that the AAMC report had by including university leadership and industry.

 Rather than engaging the associations, the staff at IMAP has selected to cherry pick “friends” who are former and current association leaders and officers to write the report. 

The report will be closer to the Macy Report in that it will come from a single perspective and the participants will have their names and affiliations listed at the end as authors to give the impression of society endorsement without having to go though the trouble of getting the actual buy in of the medical societies and their leadership.   

The report will be released with much fan-fair, including articles in major papers who will write this up as a seminal event.

The report will outline the current “problem”: industry cooperates with associations on sponsorships of exhibits at annual meetings, grants to support CME, support of data registries, and other activities and then direct associations to loose all these ties with industry in the interest of “professionalism” and include an outline on how to implement the proposed policy with no realistic plan to replace the lost income to the societies.

Though I think that these types of efforts are useful in helping to define potential problems and proposed policies and procedures, they fail to get the input of all parties effected by their proposed policies, and are usually from a single perspective, leaving them suspect of exclusion.

To understand just how effective the Prescription Project and IMAP are and how they work hand in hand I encourage you to read the recently published JAMA article by David Rothman, MD the Director of IMAP: New Developments in Managing Physician-Industry Relationships in JAMA

Physician Payment Sunshine: No Good Deed Goes Unpunished

Several months ago, I met a young woman who was the chief lobbyist for a well know anti-industry group.  In our discussion she mentioned that her group was in favor of the revised Physician Payment Sunshine Act, because they see it as a first step in their march towards eliminating all pharmaceutical and device marketing.  She explained how this data would be useful in embarrassing physicians not to work with industry.  At the time I shrugged off the comments due to her youth.

This week Eli Lilly announced that as a company they are going to disclose payments to physicians.  At this announcement one who expect accolades from those who have been saying “we want disclosure”.

Senator Kohl the sponsor of the physician payment sunshine act stated: "Eli Lilly is leading the charge for transparency in the relationship between pharmaceutical companies and doctors by fulfilling the obligations of the Physician Payments Sunshine Act before it has been enacted,"  and  "It takes a lot of courage to be the first. They have made a principled decision that I believe will benefit both their business and the consumers of their products."

So what did the anti-Pharma crowd do, did they applaud the effort, like any reasonable person,  absolutely not,  they even went so far as to accuse Eli Lilly of atrocities. 

In one of the most conflicted and prolific of the pharma critics,  Carlat’s Psychiatry Blog  Eli Lilly: Ethical Confusion Continues  Dr. Carlat writes:

So why do I say Eli Lilly is "ethically confused"? Because they still shamelessly participate in marketing deception. They hid risks of Zyprexa from doctors long after they knew about them, and still deny that this was wrong. They continue to fund a malpractice insurance company, PRMS, to provide sham risk management education to psychiatrists in an effort to prevent them from switching patients to less toxic antipsychotics. In this particularly ugly marketing tactic, they are paying attorneys to do their "education," payments which would remain hidden even under their new disclosure policy.

The blog is a case study in that the true goal of the anti-medical manufactures crowd is:

A)    To stop all new drugs from coming on the market

B)     If this drug slips by the FDA disavow and discredit any benefit that a new drug or device may bring

C)   Stop all pharmaceutical marketing.

Dr. Carlat is influential, when I pulled the records from a anti industry marketing hearing at one of the states, it was full of blog postings and articles from Dr. Carlat.

The words of Dr. Carlat once again confirm their true agenda and that no good deed goes unpunished.

NLARX: Singing the Blues in New Orleans

Several months ago National Legislative Association to Reduce Prescription Prices (NLARX) announced that their satellite symposium at the National Council of State Legislators (NCSL) in New Orleans held today, July 25, 2008 was going to be a discussion on legislative victories they had won in New York, Massachusetts and Washington, DC.

The agenda has changed in the last few weeks to:  A Shot in the Arm: New Lessons in the Battle to Save Drug Costs and Protect Patients: . Now the discussions are on the success of the panel from last year’s meeting (that’s right they had a good time last year so why not talk about it) and the 3-state New England collaboration to provide objective drug information to prescribers ("academic detailing"), legislative campaigns to ban gifts to doctors and license drug sales reps, and the latest news on federal legislation and Congressional investigations into drug marketing tactics  (apparently they want to discuss their victories in important states of Maine, New Hampshire and Vermont).

If one was going to discuss victories perhaps they would have some victories to discuss, but not this group. I guess if you have booked the room and the speakers you might as well make the best of it.

I once had a friend who went to the French War College in Paris. Another military friend made light of the fact that what they were going to learn about famous French military victories would be a short list (actually you type it in Google and it takes you to perhaps you made a mistake (see link). 

This conference promises to be the equivalent of studying famous French war victories; a lot of pride but not much for wins.

Perhaps the legislators around the country are finally waking up and realizing that pharmaceutical and device companies are not the “villains”, that they bring jobs to our states, and new medicines that eventually save lives.

At the beginning of this year dozens of bills were introduced throughout the country in state legislatures proposing everything from banning gifts to physicians (and gifts means all work), to restrictions on prescription data and disclosure laws.  Not a single state took them up (DC is a city with a corrupt city government making deciscions by local favors - you pass my bill, I will pass your bill, you want a street paved... to get a licensing of sales reps bill; “I think I will yawn”).   Massachusetts is still considering a bill that the house passed, that would codify the PhRMA code, which is a reasonable proposal by any strech of the imagination, and the provision for academic detailing is an earmark for University of Massachsetts School of Medicine not much competition or transparency here.

Fortunately, there is a Latin phrase that is my favorite in working with state legislatures and that word is Sine Die roughly translated (without a confirmed date, end of session, all open bills are dead).  At the end of every legislative session in most state legislatures they end with the two word ending “Sine Die”.

So, I am sure there is much to learn in their confernce about what could have been and why we all need “academic detailing.”  But in the end it is SINE DIE this year to all those really bad ideas.

Part of the NLARX invitation includes “Be sure to stay over Friday night so you can attend our event and the closing extravaganza featuring Cajun Zydeco music and much more”; at least they get to party to the Blues this year.  (Hey I thought legislators couldn't party, can you imagine if this was a physican meeting with a "closing extravaganza featuring Cajun Zydeco music and "much more"   --- NLARX would make announcements that because of the influcence of Zydeco music and "much more" it would be the end of medicine as we know it)

Sine Die

Disclosure = Wanted for Intimidation

So what do these groups advocating "doctor disclosure" really want from government mandated public disclosure laws? 

The answer to that question was published recently on NLARX’s (National Legislative Association on Prescription Drug Prices) website, in a slide presentation entitled: State Laws Requiring Disclosure of Gifts and Payments to Health Providers- What’s Effective and Why? by Peter Laurie of the Health Research Group at Public Citizen (one of Ralph Nader’s groups). 

And, guess what we discovered?  Disclosure laws are being promoted to facilitate investigative reporting by journalists.

The laws Laurie highlights require reporting "gifts" to doctors as low as $25 (Maine and Vermont) or $100 (Minnesota and West Virginia).  In many instances, a "gift" is defined as anything of value and this can include any work done by a physican in collaboration with a company!

In brief, it appears Laurie and his friends believe doctors should face at least as much scrutiny (and perhaps more) than a member of the US Senate.  For instance, Senators are required to report gifts aggregating more than $335, but gifts less than $134 aren’t counted!

In his presentation, Laurie defended the idea, answering the question: “Why a Doctor Gift Registry?”

(click to enlarge)

First he says, it would:

• Provide accountability and transparency to patients. ("Doctor I am dying of a heart attack, but wait let me look to see if you consulted with any companies"  This is not likely to happen and I am not sure if a patient knew Doctor X consulted for a company most patients would see that as a bad thing as they would like to be seen by an expert.)
• Restore trust in medical profession (exactly how does publishing a list of what doctors earn add to restored trust?)
• Transparency/accountability to providers (this is to promote professional jealously, "I saw you made X.")
• Transparency/accountability to payers (is this really in the best interest of the physician to be questioned on yet another point by CMS, the state, or their local PPO or HMO?)
• Promotes research (esp. if names provided).  (just what research does Laurie have in mind?  The one type of research he mentions is another point -- that the laws would: "Facilitate investigations by journalists." 

Who else could use this data for research? CMS, insurance companies, even trial lawyers come to mind….!

The proposed legislation on the NLARX website, advanced in conjunction with “The Prescription Project,” would require a national, published, and continually updated list of any doctor who has received a gift as well as the type of gift.  This information would be a matter of public record.

We don’t know what Laurie actually said verbally when he presented the slides, but the only point he expanded on is about journalists. Here is his next slide:

(click to enlarge)

He outlined journalistic investigations with these points:

·    Comparisons by specialty

·       Links to “thought leaders”

·       Links to state disciplinary actions

This all sounds so innocent, except when you put it in context that this data will be used to dissuade physician inventors and researchers from collaboration with industry.   I guess that means to save a few bucks we have resorted to articles in newspapers about "greedy" doctors, who are actually decent doctors devoted to bringing on board the next generation of lifesaving treatments.   

Or consider that trial attorneys will use this data to include in their lawsuits all physicians involved in the creation and marketing of drugs in question.  Who will want the hassle of developing and bringing to market new therapies, if people will try to ruin their lives for their effort?

In the end we will look back and wonder what trust will be restored from these initiatives?

Prescription Project

The prescription project which has been leading the charge against our industry has the following legislative agenda in this order:

A)   Transparency (PPSA) is a means to an ends (get the data and use it against the companies)

B)   Eliminate all “gifts to physicians” by drug and device manufacturers

C)   End commercial support of CME

D)   Replace pharmaceutical sales reps with academic detailers

It is interesting to note that in their blog postings they help connect the dots, that the editor of JAMA is an advisory board member, and that the lead Author of the JAMA paper is a member of one of their partner groups…. (see below)

Ghostwriters on the sly   (Prescription Project Blog)

In a companion editorial, JAMA editor-in-chief and RxP advisory board member Catherine D’Angelis M.D. decries the practice, writing, “it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors.”  The lead author of the paper, Dr. Joseph Ross of Mount Sinai School of Medicine in New York, is a member of the National Physicians Alliance, a partner of the Prescription Project.  Prescription Project (Friends are friends forever)