Massachusetts: "Gift Ban" Remains Intact

As if the Massachusetts political process wasn't enough of a circus, the Massachusetts House of Representatives decided to ramp up the drama by introducing a bill that would repeal the so-called "gift ban" (previously covered HERE) with the legislative session rapidly coming to an end.

What Happened?

Despite positive media coverage of the repeal and direct appeals from healthcare providers, the bill seems to have quickly been jettisoned when things heated up in the final 48 hours of the legislative session.  So the the ban remains intact. Why the conference committee canned the amendment is unknown beyond the State House walls, but that secret is unlikely to remain hidden for too long -- stay tuned for future posts on that topic.

Why Now?
Some speculated that the decision to repeal the ban was simply good legislators coming to their senses and realizing the effort was ill-conceived.  Others speculated it was the good work of the Massachusetts Restaurant Association, who have been actively touting the unintended consequences of the ban on their business. The other most prevalent argument is that the Association set the stage, but it was the Senate's refusal to play nice with the House on other legislation (gambling legislation, believe it or not) that prompted what could be interpreted as an affront to the Senate President. She was the sponsor of the "gift ban", so there seems to be some logic in the latter. In all likelihood it was a combination of all of the above.

Who Were the Players?Regardless of what prompted the bill and despite a short window to mobilize, the bill generated a ground swell of support from the medical community. A steady stream of communications were emerging from healthcare practitioners from around the state and the medical blogs were buzzing as Massachusetts physicians shared their perspectives from the front lines. In two interesting posts on MedPage Today, physicians tackled the negative impacts of the ban on opportunities to engage with colleagues while learning a little something new (HERE) and analyzed who were the winners and the losers from the ban (Spoil Alert: Answers - Insurers and patients, respectively) (HERE).  The posts obviously struck some chords, check out the comments and see for yourself!

Along with members of the health care community that value being able to make decisions for themselves (i.e., who they interact with, what information they access, etc.), restaurants and convention centers supported the repeal since it directly impacted their businesses. However, what was lesser known was who was pushing to keep the ban in place. Luckily the WSJ Health Blog cleared that up nicely for us HERE.  Apparently, Health Care for All, took some time to celebrate their victory on their website. (Note: The pictured billboard is owned by the International Brotherhood of Electrical Workers 103.  Before launching support for this effort, they ran the "Stop Biotech Looting" campaign HERE.)

And Who Are They?

Health Care for All, is a very active lobbying organization that works closely with Community Catalyst, who have a strong connection to another organization that could be considered 'ground zero' of the conflict of interest (COI) movement: Pew Prescription Project.  Prescription Project has been actively working to sever physician-industry interactions by promoting highly restrictive COI policies at academic medical centers as well as within state legislatures. They co-authored the Brennan et al. (JAMA 2006, subscription required) that laid the foundation for such policies. Interestingly, none of them listed their affiliation with Prescription Project or other activist organizations. Hhhmmm, fighting for disclosure for some but not all, apparently. Although, one blog post can't fully depict the ties between these organizations, hopefully over time you'll notice that it is the same actors making the same arguments with the same highly limited evidence to promote policies that restrict interactions.

What is Their Goal?

If you can answer that, post a comment!

Boston Business Journal: "Docs in the Dark"

The proposed repeal of the MA "gift ban" has moved to conference committee where three Senators (Benjamin Downing, Karen Spilka, Bruce Tarr) and three Representatives (Garrett Bradley, Brian Dempsey, Viriato deMacedo) will hammer out the differences between the two
versions of the bill, and therefore will determine the fate of the repeal.

The article highlights the basic arguments for and against the ban, and contrary to usual coverage, does a decent job of highlighting some of the more nuanced arguments for repealing the ban (i.e., collaborations beyond just marketing interactions are hampered) and exposes the  limitations of arguments for maintaining the ban: There is no evidence to support the premise that the ban will reduce heath care costs. 

Based on the quote provided by those supporting continuation of the ban, "We got some numbers from the Division of Insurance saying that drug costs have risen more slowly than other health care costs this past year. We can’t say for sure that the gift ban is responsible, but it’s interesting,” it appears that they should do a little brushing up on their economics.  As a start, they might consider reading Chaos and Organization in Healthcare by Drs. Tom Lee and James Mongan of Partners Healthcare fame. By no means industry shills, they point out that removing privately owned pharmaceutical companies from the healthcare cost equation would reduce total healthcare expenditures by ~1-2% for only 1 year. Not much of an endorsement of the "evil pharma" is driving up our costs argument.

We'll let you judge of the rest of the arguments ... feel free to leave a comment to spark some discussion...

Collaboration Gap
Gift ban is keeping some docs in the dark, hurting innovation

Boston Business Journal - by Julie M. Donnelly

For Dr. David Miller, it was a small act of civil disobedience.
“I was at a booth at a conference, and the sign said doctors from Massachusetts couldn’t take a cup of yogurt. It’s insulting — if I can be bought for a yogurt, I’m in the wrong business,” said Miller, an allergy and asthma doctor from North Dartmouth who has previously been a clinical researcher for potential new drugs. The asthma specialist often gave talks to peers about the latest treatments at events paid for by drug companies. Now those have been completely halted.

He said his invitations to events have been curtailed and suspects that his recent application to serve on the medical advisory board of a pharmaceutical company was rejected because the company did not want to deal with the onerous reporting requirements mandated by the law. He’s had it.

“I took the yogurt and said, ‘arrest me,’ ” he said, only half-jokingly. He explained that never in his talks did he endorse a specific product, and that it’s actually forbidden by the code established by the national industry organization, PHRMA.

Miller’s stint as a renegade may be coming to an end. The repeal of the controversial pharmaceutical and medical device gift ban, which, among other things, prohibits doctors from accepting food at conferences or restaurant meetings, is gaining momentum. Yet the repeal, recently approved by the House, faces an uphill battle in the Senate, where the gift ban has previously been supported by Senate President Therese Murray. Miller’s fear of being ostracized is backed up by a recent survey conducted by Dan Wolf, a recent graduate of the joint Harvard/MIT Biomedical Enterprise program.

“The most surprising thing I found is that the majority of doctors felt that the ban would hurt patient care long-term,” Wolf said.

The survey included 24 doctors in specialties including orthopedics, cardiology and general surgery. It also included executives from 16 medical device companies. Wolf said the burden of the ban is particularly acute in the medical device industry, where much of the innovation comes after market approval, when doctors advise companies on their experience using devices such as heart stents or knee implants. Most doctors surveyed, 83 percent, said that the law has led to an impaired ability to collaborate with industry to develop new devices. Medical device executives at six companies said they chose not to invite Massachusetts doctors to events this year, and according to Wolf, one company said it had removed Massachusetts doctors from its medical advisory board.

House Speaker Robert DeLeo said the law conflicts with other economic development efforts to attract companies to the state, and is hurting convention business. “We invite companies to come here, then whisk away the welcome mat,” he said.

“I’d have a problem if we were talking about taking doctors to an island or something. But for someone to be violating the law by giving someone a boxed lunch at a conference? No. It’s gone too far.”

But Brian Rosman, policy director at the nonprofit Health Care for All, said that the law is designed to drive health care costs down, and that some preliminary data shows it might be helping. “We got some numbers from the Division of Insurance saying that drug costs have risen more slowly than other health care costs this past year. We can’t say for sure that the gift ban is responsible, but it’s interesting,” Rosman said. A 2008 study from the Journal of the American Medical Association found that the industry-physician interaction does create a conflict for doctors, potentially contributing to drug costs doubling from $64.7 billion to $132 billion between 1995 and 2000.

“Most providers are honest, but let’s get rid of the whole equation. The doctors and patients I’ve talked to say they are glad to be rid of the intrusion (of drug sales reps) into the doctor-patient relationship,” State Sen. Mark Montigny said. Montigny was the original sponsor of the gift ban bill, and he is determined to keep it from being overturned.

The Senate announced this week that it will not concur with the House version of the Economic Development bill, and has appointed members to serve on a conference committee to work out the differences. The two chambers have two weeks to agree on a final bill before the legislature adjourns for the session.

Montigny says the repeal of the gift ban doesn’t belong in the economic development bill. He said representatives are mainly responding to constituents in the entertainment industry who have lost business as a result of the ban.

“Why the House found it necessary to pander to a few whining restaurants, I don’t know. There are lots of other things we can do to help restaurants, but don’t corrupt health care policy.”

Academic Detailers: No Really, We're Not Biased

As the debate heats up over whether physicians should be able to interact with commercial entities such as industry sales representatives and scientists (HERE), the Globe has thrown their weight behind funding the group they hope will move in to fill the educational vacuum: State-sponsored, non-profit sales reps called "academic detailers."

Although every attempt is made in the editorial below to distinguish the lofty motives of academic detailers from their sinister for-profit counterparts, their job descriptions seem strikingly similar: Show up at physician's offices with clinical information and attempt to influencing prescribing decisions.

Of course, there are differences. The for-profit reps have to abide by FDA guidelines and labeling; the non-profit side doesn't need to be limited by these constraints. The commercial side makes no delusions about their biases; they hope their product will be the right choice for some patients and in that case it will be selected. The non-profit side, however, seems reticent to admit that they could have any bias. To the contrary, they would have us believe that since they are paid by the State, and aren't beholden to stockholders, they are unbiased.

That argument may fly in some circles, but the rest of us may be a little skeptical. Academic sales reps are paid by the State to save the State money, yet we are to believe that they do not have a predisposition for the cheapest treatment available?


Side Note: Here is a great quote from the Godfather of academic detailing, Jerry Avorn, a staunch supporter of limiting interactions between all commercial entities and physicians, during an interview with NPR (HERE) on whether academic sales reps should be able to provide lunch while providing their education:

"Well, we actually had a soul searching about the lunch. We originally started out by saying, we’re not going to do any bribes, we’re not going to give any freebies. And then some of the doctors said, I’d really love to talk to you but the only time I have is during my lunch hour, can you bring me a sandwich. So we crossed the line and said yes, we’ll spring for a pizza or a sub sandwich but not for a meal at Anthony’s Pier 4." - Jerry Avorn, MD


GLOBE EDITORIAL

Doctors need unbiased info, not a soft sell by drug reps

July 11, 2010

TO UNDERSTAND why doctors need an objective way to learn about pharmaceuticals, look at how information usually gets to them.

Meet Dr. Jeffrey Geller, a charismatic family doctor at Greater Lawrence Family Health Center. He stopped attending lunches sponsored by drug companies in recent years. But he still accepts free samples from drug company representatives who drop by his office, because they allow him to offer the latest asthma inhaler or a dose of Viagra — neither of which would be covered by his patients’ health insurance — to the poor and underserved that come to this community clinic. Even during brief exchanges, where he signs off for a sample and basic information about a drug, he is on guard, he said. The drug company representatives are often attractive, sharply-dressed, and charming. Talking to them and looking through their snazzy brochures about the drugs they promote, he says, can make a doctor feel obligated or subconsciously swayed to prescribe their drugs. Like most doctors who are surveyed about the subject, Dr. Geller says he’s wise to the subversive influence these drug representatives can have, but he still worries about their effect on what doctors prescribe.

As Massachusetts seeks to get its health care spending under control, the state has taken a small step toward reducing the influence of paid marketers, at least on the overworked doctors at community health centers. Two years ago, the state started sending out its own representatives to provide unbiased information on diseases, clinical trials, and treatment options — all prepared by doctors and drug researchers at Harvard Medical School. When delivered by trained circuit-riders, this information can balance the one-sided pitches that doctors receive from paid marketers. Yet the limited scale of the initiative underscores the need for objective information not just in community health centers, but across the medical profession.

As of last year, Massachusetts has had stricter rules about drug company interactions with doctors than most other states. The Commonwealth bans gifts from the companies to doctors, and requires companies to report payments to doctors for services that are greater than $50. But at community health centers that serve mainly the poor, drug representatives wield influence. They drop by for chats with doctors about their drugs, and sponsor lunches to talk to nurses.

Pharmaceutical company representatives save doctors’ time by giving them slick and easy-to-digest promotional materials about their drugs. They give them flexibility, by providing free samples they can share with their patients. The problem is that drug company representatives do not provide a balanced view of how to treat an illness. They don’t tell doctors that medicines other than their own — or alternatives to medication — could be safer or more effective, even when the evidence points in that direction. And drug company representatives don’t tell doctors and nurses that their new, brand-name medicines might not be the best option for patients with poor prescription coverage and little money to spare. Even their free samples may interrupt a patient’s routine care.

In contrast, the representatives sent by the state tell doctors about the risks, costs, and effectiveness of various drugs. The method, called academic detailing, has been shown in other states and in Australia and the Netherlands to save insurers and the health care system money, on balance, by decreasing prescriptions of brand-name drugs and improving health outcomes. One of two academic detailers in the Commonwealth, Barbara Russell, has been making visits to the Lawrence center this year. But the state-funded program may not be able to secure funding to scale up or continue past the coming year.

At $250,000, the pilot program pales in comparison to the academic detailing program in Pennsylvania, where 11 detailers and more than $1.5 million in state funding are devoted to providing doctors with unbiased information about drugs and disease. Both to save money and better promote public health, Massachusetts should ramp up its effort on this front.

Doctors need the ability to treat their patients based on good science rather than good marketing.

Editorial Link HERE.

Gift Ban Repeal: How They Voted

As covered in the last post (HERE), the Massachusetts House of Representatives passed its version of the economic development bill yesterday. Normally, such an event would garner little interest locally and zero interest nationally. However, this particular bill could easily be a watershed moment for the conflict of interest movement that distinguishes Massachusetts as both the state with the most strict regulations on pharmaceutical/device maker marketing and the only state to repeal such regulations!

Of interest to the "locals" living under the regulations is how our public servants weighed-in on the issue. Below is the "Yea and Nay No. 427" report for a proposed counter-amendment which would have removed the "gift ban" repeal (thereby leaving the ban intact). For those that contacted their legislator, here's the moment of truth! A "yea", or a "Y" next to their name, means they think the gift ban should remain in effect. 

And for those that enjoy the nitty-gritty of politics, here is a transcript of the debate as reported by the State House News.  Mostly rehashed arguments, but interesting nonetheless to peer inside the process:

GIFT BAN PRESERVATION: Rep. Wolf offered an amendment striking section 105.

Rep. Wolf said the bill would repeal the gift ban we passed and the governor signed that does not allow the wining and dining of people in the medical industry and has restrictions and parameters around which information and education can take place between pharmaceutical companies and members of the medical profession. The provision was put into the original bill to keep the costs of pharmaceuticals down.

Many years ago Congress overturned previous bans to advertise pharmaceuticals and we see them advertised every day. A number of activities go on that are part education and are done at great expense of the companies and add to the expense of pharmaceuticals. Keeping down health care costs is the unfinished business of health care. The amendment hopes to not allow a provision to go down the drain so quickly after we passed it. I don't think we have had much of a chance to test out the ban. It's ludicrous to think that members of the industry might not be able to pay for their dinners. Think about what it would be like if we get rid of the bans we have with lobbyists. All hell would break loose. I don't think this is any different. Special interests going in and having the potential for increased health care costs is not in the interests of our constituents.

Rep. Dempsey said he opposes the amendment. I thank the members for their hard work today. The bill is a much better bill because of all of your hard work, bipartisan efforts. The amendment is one in which many members have passionate feelings about. We respect the sentiment around what we did a couple of years ago. At the time the discussion was centered on cost containment and if we could limit marketing efforts by pharmaceutical companies and the amount on educational dinners that that is somehow going to help us reduce the cost of prescription drugs. I never really believed that our efforts would actually lead to a reduction in cost but I did think it would elevate the discussion about the need for ethical behavior. It has served a useful purpose and been positive in enlightening folks to think about those issues. This has not saved any single person in the commonwealth a dime in what they are paying for prescription drugs.

It's a great theory that it will translate into reduced costs. I haven't seen it. I don't think anybody has seen it. If a publicly traded company is going to reduce its marketing budget it will be shifted to neighboring states or go into the dividend they are paying their shareholders. It's not coming back to the consumer. What we know is we have seen the loss of some convention business. It does not get the attention it deserves but we have seen a reduction in medical training and clinical research. The ban we have adopted has sent out a message, a chill on opportunities for training and clinical research. This has had an impact on the restaurant business but more importantly on clinical research. It's one of our natural strengths. The time has come to rethink this law. I hope the amendment is not adopted.

Rep. Lewis said he supports the amendment. I understand the intent is to help restaurants but this is not the best way to achieve this goal and we should not repeal this gift ban. We have more than 97 percent of residents now covered by insurance. The big challenge we now face is health care costs, which are causing significant hardship to our constituents. The share of family income dedicated to health care has gone from 7 percent to 17 percent. Costs are the biggest challenge facing local, state and the federal government. Prices of widely used drugs rose 50 percent from 2000 to 2006. Why is a gift ban necessary to address costs? The products offered are critical to patient health and safety but the financial relationship can steer providers away from the patients' best interests. About $9,000 is spent marketing each doctor in the United States. All of this spending is aimed at influencing prescribing behavior. A physician has a conflict if they are being paid by the company marketing the drug. The gift ban helps ensure that profits do not come before patients. More biotech is relocating to Massachusetts. There has not been a drop in convention business in Massachusetts that can clearly be attributed to this gift ban. The convention center is expanding to accommodate demand. BIO has announced its return to Boston in 2012. The gift ban is not the sole solution to rising costs and I hope before the end of the session we will take up a bill to address health care costs. It is an important component of the strategy to contain costs. It has been in place for just one year. Industry, hospitals, physicians and DPH have invested time and effort to implement the law. Rather than leaving Massachusetts, the health care industry has continued to invest and expand. Now is not the time to repeal the gift ban.

Rep. Lewis requested a roll call and there was support. Time was 6:33 p.m.

Rep. Bradley opposed the amendment. He said he wanted to give some facts. The unintended consequences of the law have been devastating and has wiped out hundreds of jobs. It has cost us at least one major convention. It's the most restrictive law in the nation. It is not a level playing field. This business is in jeopardy moving forward if business is lost to other cities. We will see a loss of jobs and tax revenues. A manager at the Seaport Hotel talked to a company from Buffalo and he said the regulations here are too onerous and that they will not come here. Also, the Mass. Convention Center now includes language in shows that allows cancellations without penalty.

Rep. Provost said she supported the amendment and noted other states are looking at gift bans. Private institutions have adopted their own bans on gifts and even on interpersonal meetings between their staff and representatives of the pharmaceutical and medical device industry. Harvard Medical School has adopted a disclosure policy for their professors, who must disclose financial interests they may have with pharmaceutical companies. No meetings were pulled out of Boston because of the law, according to an industry publication. BIO is coming to Boston in 2012. There is no evidence really that this is a loss to business. This is something to which the industry has accommodated itself and is the wave of the future. The selling of drugs and devices is not just about the bottom line. We are losing sight of patients, the individuals who come to doctors for the highest standard of care and the necessity that patients trust their doctors to consider their situation on the merits and that prescribing practices come first from the view of what is best for patients. The director of the GIC, to which we all belong, has contacted us and asked us not to repeal the gift ban. We would send the message that any law we passed, however well considered, that's up for grabs if it brings business in the door.

Rep. Feingold said sometimes when we pass laws there are unintended consequences and I am not sure we thought about medical device companies and the important role they play. I have a couple in my district. It is causing doctors to shy away to come and get trained on these devices. Understand that these companies don't have to be here. They can go to Berlin or London. We are competing against an international market. The bill we passed has had a chilling effect on the medical device industry. We have hotels that were 90 percent filled and are now 50 to 60 percent filled. If the federal government banned advertising for pharmaceuticals that would be a step in the right direction.

Rep. Malia said it's painful to listen to some of the inaccuracies. We have a crisis in medical costs. I don't think the pharmaceutical industry has been hurting over the past few years. They spend somewhere near $7 billion on marketing. I can't tell you how many times I answered the door of a pharmacy in a Boston hospital and there would be drug detailers. It was amazing. Some were nice people with degrees in education. They were not doctors or pharmacists, some were. And they would ask over and over again for time to talk to me. I said I am not a doctor or pharmacist. They had just delivered lunch to meetings, from favorite restaurants. It went on, pens, tie clips, pads of paper, everything with their names on it. I don't think it's changed much. I am very concerned about the fact that we need to stay focused on what is the most serious economic concern we have in this state, meeting our obligation for our health care costs. Repealing this ban will not help that at all. I urge you to support this amendment.

The chair opened a roll call on the Wolf amendment. Time was 6:58 p.m.

BY A ROLL CALL VOTE OF 40-108, AMENDMENT WAS NOT ADOPTED.

Not a Done Deal ... But Still a Big Deal

 

Believe it or not, the Massachusetts House of Representatives just passed its version of the economic stimulus bill with an amendment that would repeal the so-called "gift ban" intact. The bill now heads to conference committee where the differences will be hammered out. The fate of the repeal is unsure, at best, but regardless of the outcome, this sends a strong signal to other states considering enacting (similarly ludicrous) legislation.  Could the false premises of the COI movement finally be in question?

Here are some additional details on the economic stimulus bill and gift ban repeal debate from the State House News:

STATE CAPITOL BRIEFS - EVENING EDITION - WEDNESDAY, JULY 7, 2010 STATE HOUSE NEWS SERVICE

HOUSE STRIKES GIFT BAN IN EFFORT TO BOOST BUSINESS Reversing course on a new law aimed at diminishing the influence on doctors of pharmaceutical and medical device companies, the House on Wednesday voted to strike the so-called gift ban law, which critics say has hurt commerce in the medical and restaurant industries.  An amendment to preserve the ban attracted 40 votes, with 108 against.   

The elimination of the gift ban was included in economic development legislation that cleared the House 145-4 and now needs to be reconciled with a Senate bill in a conference committee.  

Critics of the ban said it was discouraging out-of-state interests from doing business in Massachusetts and said the ban had not led to demonstrable reductions in health care costs.  

  

Supporters of the ban said the state had already heavily invested itself in implementing it and needed to give the law more time to work itself out.  Ban supporters also said other states were pursuing similar bans and predicted the law could help reduce health care costs and ensure that the interests of patients, not drug and device makers, are the top priority for physicians.  

Speaking against the ban were Reps. Garrett Bradley (3rd Plymouth), Brian Dempsey (3rd Essex), and Barry Finegold (7th Essex). Pushing to preserve the ban were Reps. Alice Wolf (25th Middlesex), Ruth Provost (27th Middlesex), Jason Lewis (1st Worcester), and Elizabeth Malia (11th Suffolk). 

Massachusetts Considering Lifting "Gift Ban", Really?

The unpredictable times continue in Massachusetts ... few would have predicted that Ted Kennedy's seat in the Senate would be filled by a truck-driving, male-modeling republican from a town best known for its immense factory outlet stores rather than political dynasties. 

Similarly, few would have predicted that the Massachusetts House of Representatives would be attempting to repeal the hotly contested "gift ban" (Chapter 305 of the Acts of 2008) that, among other things, made it illegal for physicians to take a pen or have coffee with someone from the pharmaceutical or medical device industry.

Citing concerns from the biotech and medical device communities as well as the convention center and restaurants, the House leadership released its version of the state economic stimulus plan which would lift the ban. The media is in a flutter. locally and beyond the Baystate.  The Boston Herald (HERE), Boston Globe (HERE), and WSJ Heatlh Blog also covered the story today (HERE), and more continue to emerge.

Many are wondering if the Scott Brown "phenomenon" wasn't a fluke ... could things really be changing? We'll soon find out.  If nothing else, this bold move sends a strong signal to other states that may be considering similar bans and to those that have been riding the conflict of interest wave (which is finally getting some push-back, HERE).

Media Coverage

Boston Business Journal

Boston Globe

Boston Herald

WSJ Health Blog