Food Stamps for Doctors: Mass Legislature Votes Today

Today, the Massachusetts legislature will consider a measure introduced by House speaker Robert DeLeo to repeal the historic drug company gift ban law enacted only two years ago. Why? Because wealthy restaurant owners are lobbying to return the state to the days when it was a haven for wining and dining doctors.

The interesting thing is that doctors themselves have resigned themselves to the law, and have largely embraced it. For example, Partners Healthcare, which includes both Mass General Hospital and Brigham and Women’s, forbids its staff from accepting any drug company meal, on site or off-site, and has banned its faculty from giving “educational” talks at restaurants (read their policy here).

It’s rather embarrassing that Massachusetts lawmakers have decided to ignore Harvard Medical School’s example, and are instead receiving their health policy instruction from restauranteurs. The most vocal of these nouveau medical ethics gurus has been Steve DiFillippo, owner of the Davio’s chain of Northern Italian Steakhouses, Avila’s, and a new line of Davio’s frozen foods. Below is a picture of Steve posing with Mayor Menino at the opening of one of his restaurants.

Last April, DiFillippo appeared on WGBH's Greater Boston to present his own version of Medical Ethics 101: “Besides my parents," he said, "who do I trust the most? It’s my doctor. I trust my doctor to go to an educational dinner where it's doctor on doctor and learn about the drug. And recommend the right drug.”

Emily Rooney: “You don’t think they are going to be unduly influenced?”

Steve DiFillippo: “We’re talking about doctors. You know, they go to doctor school for 12 years…to become a doctor. I think I can trust my doctor to make an educational decision.”

I appeared with DiFillippo on that program. What viewers did not see was that in the pre-show lounge, DiFillippo was working the crowd. Speaker Robert Deleo happened to also be in the lounge, where he was waiting to be interviewed about his effort to legalize casino gambling in Massachusetts. DiFillippo planted himself by his side and groused about how much income restaurants were losing from the ban on free meals for doctors. It was an eye-opener for me, seeing the political process in action. DeLeo and DiFillippo obviously knew one another from somewhere. They shook hands, they smiled, they chatted--it was the ancient machinery of wealth multiplying itself by rubbing up against power.

Evidently, DiFillippo’s knew what he was doing, because within three months, DeLeo had introduced legislation to repeal the gift ban. I assume that the Speaker has his heart in the right place in that he wants to stimulate the Massachusetts economy. Unfortunately, he is willing to trade ethics for money, both in his successful championing of casino gambling (a shady recreational pursuit which has ruined several of my patients’ lives) and now in his willingness to allow drug companies to resume bribery-as-usual of Massachusetts doctors.

If you happen to be a doctor looking forward to a bright future of free meals, here is a portion of Davios’ steakhouse offerings. Lick your chops!

Trickle Down Deception: Restaurants and the Pharmaceutical Industry

Yesterday I debated Steve DiFillippo, owner of Davio's and Avila's restaurants, on the WGBH program Greater Boston, hosted by Emily Rooney. The topic? The effect of the Massachusetts Gift Ban law on area restaurants.

On one level, it was a friendly debate on the economic impact of the law on those restaurants that depend on drug company sponsored dinners for a chunk of their income. You can watch the debate here. Please don't comment on my bad hair day.

But on another level, this is a larger and more worrisome issue, which is the trickle-down effect of deceptive marketing practices on the economy, such that very good people unwittingly help to perpetrate deceptive marketing practices.

When you do these news shows you arrive a half hour early and are greeted by the producer, who brings you to a waiting room where all the other guests are sweating it out in preparation for their five minutes of fame. For example, I got to meet House Speaker Robert DeLeo, who was there to talk up his proposal to legalize casino gambling in Massachusetts. I then had a pre-debate chat with Steve DiFillippo. He has created some amazing restaurants, one of which I have a personal connection with. My wife and I had our wedding rehearsal dinner at Davio's when it was in its former location on the Charles River in Cambridge.

Steve is a completely ethical person, does great community work, and was just given the Torch of Liberty award by the Anti Defamation League. Yet, here he was arguing that drug companies should be allowed to wine and dine doctors in order to sell them on their newest drugs. From his perspective, doctors, with all their training, should be smart enough to separate the hype from the truth. But unfortunately our extensive training does nothing to immunize us from the effects of marketing, as many companies have discovered. Merck, for example, found that hiring doctors to pitch other doctors at restaurants and other venues led to four times more Vioxx prescriptions. It didn't matter how much they spent on restaurants, they knew they would get a handsome return on their investment. Unfortunately, a bunch of people who took that Vioxx died of heart disease, and the drug was eventually taken off the market. As patients, we deserve to have our treatment decisions based on the medical literature, and not on the pitches of salesmen who have softened up their clients with cabernet and filet mignon.

I think if Steve and the other restaurateurs didn't have a dog in this race, they would agree with this. But they do have a dog in the race. And when your income stream depends on believing something, it's highly likely that you will believe it.

Steve, like thousands of other business owners, is a victim of "trickle-down deception." It begins with the drug companies, and spreads and expands where the money goes. Other victims include advertising companies, medical education communication companies, publishers, lunch caterers, celebrity spokespeople, etc.... In each of these industries, there are ethical people who believe they are just making an honest buck. But they are unwittingly participating in a system that depends on a basic deception: trying to dress up advertising in the guise of education.

The solution is to simply do what we are doing--keeping a close eye on the industry and reporting their most deceptive practices. Unfortunately, when they just can't behave themselves, we have to expend a lot time and effort to pass laws regulating them. The ensuing trickle down effect of honesty is something we can all support.

Massachusetts Disclosure Loophole: "Let's Keep Research Payments Secret"

In August of this year, Governor Deval Patrick signed into law a historic bill limiting drug company payments to doctors and requiring disclosure of any other payments. The pharmaceutical industry battled the law tooth and nail before their defeat. At one point, GlaxoSmithKline actually blackmailed the state, saying it would stop doing business in Massachusetts if the law were passed.

Now that it is law, the companies are back at their shenanigans, trying to water down the official regulations that the Department of Public Health will use to enforce the bill. And they've been quite successful. As covered in today's Boston Herald, the proposed regulations do not require that companies disclose research payments to doctors.

According to John Auerbach, the public health commissioner, the regulations were written this way for fear that forcing disclosure of such payments would keep clinical trials out of the state. Wait a minute--this sounds exactly like the bogus industry arguments that failed to prevent the bill from passing in the first place!

The fact is that doctors are paid millions to conduct research studies, and we have a right to know this information. If there is truly nothing wrong with doing research with industry (and I agree with this), why should the money remain hidden?

The companies argue that publishing this information gives their competitors information about their research plans. The problem with this argument is that information about clinical trials is already publically available on an online registry of clinical trials. Beginning in 2005, the International Committee of Medical Journal Editors announced that they would only consider for publication research that was posted on this registry, in order to prevent the problem of publication bias. There are currently 65,825 trials registered. So if you are Pfizer, and you want to know what kind of research Eli Lilly is conducting, the answer is only a few clicks away.

It's time for the Department of Public Health to stop meeting with drug company lobbyists and to start writing regulations that reflect the will of the people.

Governor Patrick Signs Gift Ban and Disclosure Bill

Governor Patrick stood up to intensive last minute lobbying by the pharmaceutical industry and signed a bill limiting gifts to doctors and requiring disclosure of most drug company payments to physicians. You can read coverage of this historic event here and here.

It was touch and go at the end there, as the drug industry did what they do best--pumping huge amounts of money into marketing campaigns. They bought a full page ad in the Boston Globe, and lobbied many Massachusetts legislators to write a letter to the Governor urging him to veto the bill. But in the end, people-power trumped misguided corporate interests. Reportedly, 7000 members of AARP (the American Association of Retired Persons) called the governor to urge him to sign the bill, and hundreds more sent emails.

I am proud to say that I represented the National Physician's Alliance in supporting the bill, in conjunction with Health Care for All and the Massachusetts Prescription Reform Coalition.

Kudos also to Senate President Therese Murray and Senator Mark Montigny, two of the driving forces behind passage of the bill.

And of course, congratulations to Governor Deval Patrick, who took a courageous and historic step. I knew he wouldn't disappoint us!

As Governor Patrick Searches Soul, Drug Companies Abandon Truth

It's down to the wire for Massachusetts Health Care Reform, and a corsortium of drug company interests is playing hardball to influence the Governor, as covered in today's Boston Globe here. Truth is not on their agenda.

In this full-page ad in yesterday's Globe, the companies urged Governor Deval Patrick to veto the bill known as S. 2863. The ad is filled with so many inaccuracies that it's hard to know where to begin.

1. "The legislation that awaits Governor Patrick's decision will significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts."

False. Actually, the legislation explicitly protects all biopharmaceutical research: “The marketing code of conduct adopted by the department shall allow:… 4) compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial.” ( S. 2863 Chapter 111N, Section 2)

2. "The legislation...will have a direct and immediate devastating impact on the lives of thousands of people across the Commonwealth."

False. There will be little, if any impact, largely because the partial gift ban included in the bill is the same ban the pharmaceutical industry just adopted for itself as an ethical code. Unless, that is, these companies have already been making strategic plans to flaunt their own self-imposed regulations.

The Boston Globe itself is not fooled, and the paper strongly supports the legislation in today's editorial. You can also read more details about the misinformation in the ad here, in the Prescription Project's excellent blog, Postscript.

On a more personal note, I recall having attended one of the Governor's early fundraising events in 2005, soon after he announced his candidacy. It was at the Grog in Newburyport, and Patrick gave an electrifying speech, emphasizing truth and transparency in government. Given his commitment to the welfare of the people, I am confident that he will do the right thing by signing S. 2863 into law.

Massachusetts Passes Disclosure Bill, Partial Gift Ban

After many months of debate, negotiations, and op-ed wars, the Massachusetts Legislature has passed a bill imposing strict limits on the most unethical aspects of pharmaceutical marketing. You can read more about it in the Boston Globe and in the Prescription Project website. The bill passed both the Senate and the House last night, and is now awaiting Governor Deval Patrick's signature. The provisions include the following:

--Both drug companies and medical device companies must disclose any payments or gifts to doctors valued at $50 or more. These payments will be disclosed on a publicly accessible database. This will include any payments to hired gun physicians who are on company speaker's bureaus, but unfortunately will not include third party payments in which medical education companies launder drug company money and cut checks to physicians for industry-funded CME programs. This means, for example, that Pri-Med will still be able to convene its many industry-funded CME meetings in Boston and the physicians will not have to disclose how many thousands of dollars they are being paid to focus on topics of commercial interest to the sponsors. Overall, this is a partial win for transparency. I'll take it!

--The Massachusetts Department of Public Health is directed to establish legally binding regulations governing the giving of gifts to doctors, regulations that must be at least as stringent as the recently announced PhRMA code, and may be more stringent. As I covered in a prior post, the new PhRMA code requests that companies no longer give tchotchkes to doctors (eg., mugs and pens) but allows in-office lunches. This is a purely voluntary code. The new law transforms this voluntary code into state law, and establishes a $5000 per violation fine to enforce it. Note that this is not a draconian fine to be paid by physicians, as a prior version of the law stipulated--this is payable by the drug companies if they skirt the regulations.

--Massachusetts must establish an academic detailing program to provide unbiased medical information to physicians. This will be similar to the successful Pennsylvania program already in operation.

Overall, this compromise bill is a great step forward, and I congratulate the many committed organizations that made this happen, including Health Care for All, the Prescription Project, and the Massachusetts Prescription Reform Coalition. Let's hope the governor signs the bill into law sooner rather than later!

Did Drug Company Gifts Kill the Gift Ban?

In April, the Massachusetts State Senate passed a total ban on all drug company gifts to physicians (see my post here). Spearheaded by Senate President Therese Murray and supported by many others, the ban appeared certain to be approved in some form by the House, and Massachusetts could have bragged about taking the hardest line of any state against this form of legalized bribery.

But in what must go down as one of the greatest ironies in political history, the legislators visited BIO 2008, a massive Biotech conference in San Diego and one of the last of the great dug company swagfests--and now even Senator Murray wonders whether gifts might be necessary for good medicine. According the the State News Service, covered here in the Policy and Medicine Blog, Senator Murray said researchers in San Diego told her the ban would prevent productive interactions between doctors and researchers who are trying to treat the same diseases. “It’s something that we didn’t discuss when we did it, because we were looking purely at gifts to doctors,” Murray said in a telephone interview with the News Service. “But the fact is that some of these companies do bring researchers and doctors together to go over the latest research.”

Wow. Something happened at the convention to hoodwink our finest legislators into believing that doctors can't learn about research without being given free lunches. I didn't attend BIO 2008, but my colleague Harry Tracy did. Dr. Tracy is the writer and publisher of NeuroInvestment, quite possibly the best single source of cutting edge information for those investing in the pharmaceutical industry. Here is his review of BIO 2008, reprinted with his permission from his latest newsletter:

“At the BIO International Convention, 24,000 attendees had the opportunity to watch companies who were limited to fifteen minute sound bites, and much of the fun was to be had in the Exhibits area, where various companies, countries, and municipalities handed out tapas, wine, single-malt scotch, novelty pens, and miniature stuffed koalas, while holding raffles for everything from laptops to trips to London. Indeed, the local paper of record, the San Diego Union-Tribune, devoted a high-profile article to the bounty of "swag" available to attendees. Apparently they overlooked the gift available at the State of New Hampshire booth, which was a plastic band-aid dispenser. While we will treasure ours forever, this stretches the definition of "swag" beyond recognition. But these silly 'Freebies' are just a minor symptom of a larger problem with public relations and perception. San Diego, as it does for other large conventions, literally walled off for an afternoon and evening a five block section of the Gaslamp District, for a BIO-only party. There were three soundstages and seemingly acres of free food laid out for the occasionally semi-intoxicated revelers. Of course, those without a BIO badge were not allowed in, the party was only for "VIP's." As much as NI enjoys VIP treatment, there was something unsettling about seeing the excluded public peering over the barriers at the party-goers. At a time when the pharma industry is widely perceived as concerned with profit rather than with patient care, at a time that the industry is under siege by the Charles Grassley's of the world who believe that the industry deserves to be taken down a notch, this seems unwise. It is probably naive to think that the industry will police its excesses, but if it does not, its losses in the court of public opinion will continue to mount, and few in the audience will protest when the guillotines are brought out.”

I don't mean to imply that Senator Murray, or any other legislators, accepted any of these freebies in San Diego. But there's no question that they allowed their opinions to be influenced in a carnival of swag. Meanwhile, BIO 2008 has announced that Massachusetts Deval Patrick is their "Governor of the Year" on the strength of his support for a $1 billion Life Sciences initiative. I assume they will honor the Massachusetts Legislature with a similar award, depending on the outcome of the vote on S 2660.

Unintended Silliness: Free Lunches get a New Cheerleader

The law banning pharmaceutical gifts to doctors continues to pick up steam, having already been passed by the Massachusetts State Senate, and now being considered in the House Ways and Means Committee. You can get a quick education on the issue by watching this NECN debate between myself and Harvard's Tom Stossel.

I recently learned about an unintended putative victim of this bill: companies that specialize in catering all those free lunches. Kevin Abt, CEO of Restaurants to You, has written this letter to his state representative complaining that not only will his business suffer, but that caterers state-wide will lose $40 million if the bill is passed.

The letter, along with 22 entertaining comments, is posted on the political blog Blue Mass Group, which bills itself as "reality based commentary on politics and policy in Massachusetts and around the nation."

Please go to this great site and read. Here are snippets from some of my favorite responses to Mr. Abt-the-caterer's concerns:

1. "Just because a drug rep isn't paying doesn't mean the doctors won't be eating lunch. This isn't going to be $40 million just disappearing from our economy. It's going to be shifted around some. I bet non-catering deli counters in the vicinity of hospitals will be thrilled to have the gift ban passed. I don't mean to be insensitive to the plight of Mr. Abt and other caterers who have made a business out of catering lunches between doctors and drug reps, but businesses are forced to adjust and adapt all the time for any number of reasons."

2. "So, let's not ban lunch-n-learns. In fact, there's no request to do so. Let's just let the doctors buy their own lunch. After all, at only $8-$20, it wouldn't be a burden on the doctor. Doctors gotta eat. So, it's not about foodz4u.com, it's about who pays for foodz4u.com. This bill wouldn't allow the drug companies to buy the food for the doctors."

3. "By his logic doctors will just go hungry if they don't get free lunches from PhRMA companies. The doctors I know, including my wife, are getting their lunches from the small local restaurants he is claiming will lose money. Of course, the last thing this guy wants is for health care workers to walk to their local restaurants instead of eating catered lunches. More and more hospitals are banning such practices in any case, so whining about it to the legislature is probably not going to do all that much good in the long run."

I might add that Mr. Abt's pulled-out-of-the-air estimate of $40 million cuts both ways. From his point of view, it is $40 million lost from the pockets of a niche food business. But from the consumer's point of view it reminds us of the enormous scale of the pharmaceutical marketing endeavor. The drug industry was once considered an important engine of research and development. But the dirty little secret is that pharmaceutical companies spend more on promotion than on research--much more. The latest analysis, published in PLOS Medicine, estimates that in 2004, drug companies spent $31.5 billion on R & D, dwarfed by the $57.5 billion they spent on marketing and promotion.

I suggest the Mr. Abt begin marketing his tasty offerings directly to physicians--I doubt he'll go out of business.

Carlat to Debate Stossel on Jim Braude Show

I'm not entirely certain why I agreed to this, but I am scheduled to debate Tom Stossel on NECN's Newsnight with Jim Braude. It should air Monday night, June 2, at 8 pm. The topic is the bill being considered by the Massachusetts legislature that would, among other things, ban drug companies from giving any gifts to physicians. I've covered this issue in some depth here.

My opponent has an impressive pedigree, and is an eloquent spokesman for the view that there should be more, rather than less, interaction between physicians and drug companies. This site has links to many of his articles on the issue. I believe that John Stossel, the ABS news anchor who rants against various liberal causes, is Dr. Stossel's brother. If so, I hope he won't be receiving too much coaching from his famous debate-champ brother before Monday.

Tune in if you have a chance.

GlaxoSmithKline Executive Blackmails Massachusetts

Health Care Renewal discusses a disheartening development in the debate over the Massachusetts' law to ban drug companies from giving bribes--I mean, "gifts"-- to physicians. In the past, I wrote this rambling post about the issue, including links to several letters and editorials printed in the Boston papers. The latest article, published in the Boston Herald, quotes the head of GlaxoSmithKline's operation in the U.S. as implying that if the full legislature passes the ban (the State Senate has already done so), GSK will take their money out of Massachusetts and head to other states that do not "demonize" the pharmaceutical industry.

Yawwwwn. It's a threat we've heard before but it's actually quite embarrassing for GSK. Why does the company believe it needs to give pens and pizzas to doctors in order to get them to prescribe their drugs? Are their products so ineffective that bribery is the key incentive for their use? Read this excellent letter in rebuttal, written by Marco Cornelio, a medical student at Tufts. Cornelio writes, in part, "Instead of spending their money on such bribes, pharmaceutical companies ought to be using it for research to produce truly innovative, effective and safe medications."

Massachusetts Senate Passes Drug Company Gift Ban

On April 18, the Massachusetts State Senate unanimously passed a law that included a complete ban on any gifts from the pharmacetical industry to doctors in the state.

This ban was only a small part of a larger bill to control health care costs in the state, but it is the provision inciting the most controversy by far. At this point, the bill is headed to the state House of Representatives, and then to the governor, so the ban is not yet a fait accompli.

It’s been highly entertaining to see how the issue has been playing out in the blogosphere and in local papers. The first salvo came in the form of this op-ed in the Boston Globe by Christopher R. Anderson, president of the Massachusetts High Technology Council. Among other things, Anderson argued that a gift ban would hurt the state’s biotech industry by “undercutting biopharmaceutical employers that are expected to create jobs here.”

Boston’s conservative paper, the Boston Herald, then chimed in with this editorial, which quoted a letter from four drug companies complaining that the gift ban would hurt business and implying that drug companies would take their money to other states if it were enacted. The Herald said that the gift ban would “kneecap” the life science industry in Massachusetts.

Wow. How demeaning to both drug companies and doctors. Apparently, the only way to succeed as a pharmaceutical company in Massachusetts is to bribe doctors to use your products. And here I thought business success depended on creating valuable medical treatments that offer real advantages over competitors.

By the way, if companies believe they can flee regulation of their marketing practices by leaving Massachusetts, they’re wrong. Minnesota bans gifts worth more than $50, and Vermont requires public disclosure of gifts over $25. And according to this legislative round-up from The Prescription Project, in 2007 over half of all state legislatures considered bills addressing various aspects of bribery-based pharmaceutical marketing.

Furthermore, many of the country's premiere academic medical centers have already banned drug company gifts in their facilities, including Yale, Stanford, University of Michigan, University of Pennsylvania, Boston Medical Center, Vanderbilt University, University of Pittsburg, and University of Massachusetts. The huge University of California system is now in the process of formulating its own gift ban.

There truly is no place for drug companies to hide. A better solution is for the companies to scale back their marketing to traditional and legitimate practices, such as advertisements in medical journals.

At any rate, the Herald then published this perplexing op-ed written by two Boston physicians, supposedly arguing against the gift ban. The perplexing part of the article is that they actually claim to support gift bans in academic medical centers, and furthermore, they readily admit both that the reason drug reps call on doctors is to get them to prescribe more of their drugs, and that cheaper generics are often just as effective as newer, expensive agents, which, they say, "may add only incremental value." Thus, they don’t seem to be arguing against the gift ban per se, but rather they appear to believe that this bill is the first step in a darker liberal agenda: “The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry.” Talk about conpiracy theories. There's nothing in the bill eliminating, or even discussing, payments for CME activities or industry funding of research. Come on people, enough with the straw man arguments.

The credibility of the editorial was severely damaged by the conflicts of interest of the writers, which were only partially disclosed in the article. The disclosure noted that Dennis Ausiello is a director of Pfizer, but did not also note that he is on the advisory boards of three other drug companies. Tom Stossel disclosed no COIs at all, despite the fact that he is on Merck’s advisory board and receives payments for various speaking and marketing activities from four other companies. No wonder their editorial, ultimately, fell on deaf ears in the State Senate. You can read more details in two articles in Pharmalot and the Wall St. Journal Health Blog.

Meanwhile, the battle for public opinion has been spiced up by several letters to the editor, including here and here by yours truly, these two pro-bribery letters (one by a physician's husband and the other by the CEO of a promotional products company), and here by Lisa Kaplan Howe of the Massacusetts Prescription Reform Coalition, which is a group I work with.

The fact is that our patients want us to base our prescribing decisions on an objective reading of the medical literature, rathet than a hard sell from professional salesmen. And bribery? It’s time to delete the term from the pharmaceutical industry’s lexicon.