It's time to rein in Big Pharma

By State Representative Carolyn Tomei of Milwaukie, Oregon.

In this week's Journal of the American Medical Association, some of the country's most distinguished medical doctors and health policy experts urge the nation's physicians and medical centers to stop accepting handouts and gifts from pharmaceutical companies and medical device makers.

In the report, these doctors admit that voluntary disclosures by physicians hasn't worked and that "...research in the psychology and social science of gift receipt and giving indicates that current controls will not satisfactorily protect the interests of patients." In other words, these gifts are bad for patients. They urge the nation's academic medical centers -- places such as OHSU -- to lead the way in reform.

The group made a series of recommendations to reduce the influence of drug companies, most notably calling for "stringent regulation" and possible elimination of the "common practice" of providing physicians with small gifts, pharmaceutical samples, travel to medical conferences, speaking honoraria, and consulting and research contracts.

In April of 2005, I led a public hearing on HB 2817 (pdf), which would have required pharmaceutical companies to disclose "any gift, fee, payment, subsidy or other economic benefit" provided to physicians, hospitals, pharmacists, and other health care professionals. Articles in recent days discussing the JAMA article have noted that drug companies spend $20 billion each year on marketing, around 90% directed at physicians. See the Washington Post and NPR.

During the hearing, health care professionals, consumer advocates, representatives from senior citizen groups, and everyday Oregonians testified in support of HB 2817. There was overwhelming public support for this measure, and testimony that reining in these practices would not only eliminate potential conflicts of interest but help slow down rapidly rising health care costs. But the committee chair, Rep. Billy Dalto, would not allow a vote on the measure.

On June 27, 2005, other House Democrats and I tried one last ditch effort to free this bill and bring it to the floor for an up or down vote. Unfortunately, Speaker Minnis and the Republican majority leader Wayne Scott gave their members instructions to kill this bill. The motion died on a party-line vote.

I'll leave it up to you to determine whether or not the roughly $78,000 that Minnis, Scott, Dalto, and Majority 2004 received from the pharmaceutical and medical device industry last campaign cycle had anything to do with HB 2817's demise.

One thing is for sure: I will be reintroducing HB 2817 next session, and this time we'll have the nation's leading health care experts on our side.

  • KatSwing (unverified)
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    Because my dad was self-employed, my family often didn’t have health insurance when I was growing up. When we did need medical care, our doctor looked for ways to help reduce costs, which often included prescription drugs the office received as samples. Recently my un-insured sister received a sample of fast-acting pneumonia medicine worth at least $50. I know that my parents wouldn’t have allowed her to go without, but I also know that they were grateful for the assistance. I hope that this bill would not reduce the number of sample drugs that doctors pass on to the uninsured, and low-income families.

  • Tom Civiletti (unverified)
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    After the oil and media industries, big pharma is the most egregious manipulator of government for selfish aims. Along with the insurance industry, drug companies are responsible for the deathly poor health system in the US.

    Representative Tomei should be supported in her advocacy of HB 2817. Go get them, Carolyn!

    KatSwing is concerned about preserving the supply of free samples that providers dispense. This practice is a little like a fellow who steals your purse and then tosses penny candy at your children as he walks by your home.

  • Representative Carolyn Tomei (unverified)
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    Hi KatSwing, Thank you for your question. My bill, HB2817, would not affect doctors giving out free samples. Almost all of us have benefitted from this practice. All it would do is require doctors and other health care professionals to make public the amount of gifts, dinners, trips and other financial incentives they are given by the pharmaceutical industry to promote their products.
    Carolyn Tomei

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    Carolyn,

    I support the thrust of your bill, but I also hope that it won't prohibit sampling. Most doctors and nurses are creatures of habit and are reluctant to start prescribing something new unless they try it themselves on patients regardless of what the literature says. Samples allow them to do it.

    I work for a medical device company that makes wound dressings and an antimicrobial gel. These are wondrous products that save lives, but it takes a long time for the medical profession to change their behavior and each one has to see the proof themselves. Once they are familiar with the product the sampling is no longer necessary, but I really do not know how you could show them it works without sampling.

  • Representative Carolyn Tomei (unverified)
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    Hi John, I want to assure you that my bill would in no way prohibit or control free samples. All it does is require the pharmaceutical industry to make public their gifts, trips, dinners, etc. to health care professials. It does not prohibit gifts or samples. It just provides public information. You keep up the good work! Carolyn

  • Ron Ledbury (unverified)
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    Opposition to the unfair exertion of monopolistic powers is just good old fashioned pro-capitalist behavior.

    I do like to hear that there is a role reversal on the issue of bribes that are not called bribes, as to this issue.

    If there is a deduction on the costs (or the true value thereof) by the drug companies for the samples then there should be a matching claim of income by the recipients. Newspapers that take adds call it income. A Dr. should call it income too.

    At 20 billion dollars that should mean that Oregon gets about 200 million (I just use a 1 per cent population ratio for ballpark numbers like these). If it was taxed as income then nearly 20 million dollars could be derived just from taxing the bribes.

    Billy Dalto and Douglass Riggs are, by the way, responsible for my future claim to call income as not income because I spent it on a good cause of my own choosing, even if it is not just for the purpose of renting space at the convention center to advocate for health care for the poor by giving Billy a pulpit.

    Tax free money to buy space for Billy to prance in public is a gift too, a campaign gift, that must be declared, both for Douglass Riggs' income and as a campaign gift to Billy (and the small set of other confused folks from Animal Farm).

    I wouldn't let the drug companies set the value of the bribes (for income taxation purposes) or they will price them like stock options, free for now because we are not smart enough to set a value, and instead price the in-kind bribes at what it would cost to obtain them in the open market from those very same Doctors that sell (or push) those drugs to their poor patients.

  • Katie Gauthier (unverified)
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    Representative Tomei’s bill just makes sense and she deserves our thanks for the tenacity to continue bringing it forward, giving us a measure to contrast between those legislators who put patients ahead of profits and those who cower to special interests.

    Just as state law requires disclosure of campaign contributions and lobbying expenditures, a similar requirement should be enacted for drug companies attempting to influence physician prescribing decisions.

    When marketing rather than objective and unbiased information shape prescribing patterns, the cost of prescription drugs for consumers, government and health insurers will continue to rise far faster than the general rate of inflation.

    Oregon has been a leader in promoting use of the most efficacious, cost-effective prescriptions through the Evidence-based research center. HB 2817 represented a next step in the process of informing patients about prescription costs.

    According to Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine, 78% of the new drugs marketed by pharmaceutical companies in the last six years were not chemically different than drugs already on the market and 68% were classified by the FDA as unlikely to be improvements over drugs already on pharmacy shelves. Yet, through extensive “gift giving” drug companies persuade health care providers to prescribe these new drugs.

    Oregon patients have a right to know how drug companies are attempting to influence health care providers. Ultimately, increased accountability over drug company marketing will lead to reductions in consumer spending on prescriptions. It’s just another reason we need Carolyn Tomei as chair of the health care committee- instead of drug company shill Billy Dalto.

  • humblerodent (unverified)
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    Keep up the good work Caroyln,

    To back up again what you said to John & Kat earlier - HB 2817 does not affect free samples but deals with full disclosure of an already shady practice by pharmaceutical companies.

    It would require drug companies to disclose annually the value, nature and purpose of any gift, fee, or subsidy they give to doctors and hospitals. Drug companies would be required to report any gift valued at over $25 to the Department of Justice. Again, free samples, scholarships, and payments for clinical trials would not be included.

    Gifts meant to sway prescribing practices erode the public’s trust in the medical profession and can negatively impact patient care. Drug companies spent more than $7 billion (not including drug samples) in 2003 on one-on-one marketing to doctors. This works out to about $8,400 to $15,400 per doctor per year. Direct marketing costs are increasing rapidly; the $7 billion spent in 2003 represents a 78% increase over 1999 levels. (Consumers Union, 2005)

    That being said - I need to go refill my Nasacort AQ coffee mug.

  • steve schopp (unverified)
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    Sure, have them report but be careful not to scare off potential investment and jobs.

    San Diego-based Amylin Pharmaceuticals, which had two diabetes drugs approved for market this year, said yesterday it will build a $70 million manufacturing facility in West Chester Township, Ohio.

    http://www.signonsandiego.com/news/business/biotech/20051223-9999-1b23amylin.html

    Ohio lands first Amylin production facility

    By Terri Somers UNION-TRIBUNE STAFF WRITER

  • Jennifer Warren (unverified)
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    I understand concerns expressed by KatSwing and John Calhoun.

    Sadly, the practice of doctors providing -sometimes lifesaving- prescription medications to their patients is, and has been for quite some time, a key component of our current health care system for the poor and uninsured.

    Years (?) ago as a teacher in a rural Maryland, I worked with many students whose families were breathtakingly poor. Even though our amazing community doctor provided very low cost -often free- health care for those families, to them a visit to the doctor was a luxury, and a cost to be avoided unless absolutely necessary.

    The free prescriptions our doctor provided were a gift, and a blessing, to low-income and uninsured patients who were either self-employed (in a rural community), or worked hourly jobs for minimum (Federal - not Oregon) wage.

    Unfortunately, the practice of providing those free meds was/is a band-aid solution (please, pardon the pun) to a bigger problem.

    As KatSwing pointed out, there were many times that her family did not have health insurance. In the end, and for all of us right now, that equates to not having access to health care.

    The issue isn't proctecting free prescription meds for people who can't afford them - it's providing people with access to quality, affordable health care - and that includes quality, affordable prescription drugs.

    A number of serious bills aimed at improving health care access and affordabiity were introduced during the 2005 legislative session - and partisanship or not, the fact is that even with unprecedented constituent and voter support, many of those bills were defeated -in the House- due to direct influence from the pharmaceutical industry lobby.

    Rep. Tomei's bill would go a long way to helping rein in the unchecked influence of the pharmaceutical companies on Oregon's legislative process. Then perhaps, we might have a chance to pass legislation that would make concerns about the free prescription handouts unnecessary.

    It's just too bad we don't have legislation similar to Rep. Tomei's at the federal level. It might have helped save millions of seniors countless hours of fear and anxiety as the work their way through the new Medicare Rx that was written of, by and for the pharmaceuticals.

  • Alice (unverified)
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    I was suffering from a sinus and upper respiratory cold before Christmas and my Doctor gave me two free nasal inhalers for the sinus congestion. It was called "Flo-Nase" and seemed very effective without any dependency (remember "Afrin"?. I bought an identical one at Fred Meyer's, and my co-pay was $10 vs. a list price of $58.

    I thought the two "free samples" were very nice: kind of takes the sting out of the $10 co-pay.

    I have read the physicians frequently give these samples away to the uninsured or patients who are unable to buy their own. While I don't fit into that category, I assume the pharma companies would do less of this type of "soft" marketing if HB 2817 is passed.

    What are your thoughts, Rep. Tomei?

  • Alice (unverified)
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    I just read the bill and see that drug samples are excluded.

    I am concerned the additional reporting requirements would discourage "small pharma" companies from marketing their emerging products.

    "We're having this conference in San Diego to discuss our latest cancer treatment, Doc, but we can't invite anybody from Oregon unless you agree to pay your own way." Probably wouldn't muster the same response as, "lodging and meals will be provided without charge to you and your spouse."

  • Representative Carolyn Tomei (unverified)
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    Alice, There is nothing in HB2817 that would inhibit pharma companies from giving out free samples. Those samples are not what this bill is about. What we are trying to do is let the public know that many health care professionals are receiving many thousands of dollars worth of "gifts," trips, dinners, speakers fees, etc. as inducements to prescribe their new and expensive drugs, many of which are no more effective than over the counter less expensive drugs. This bill would not prohibit the gifting; it would merely require it to be public information. Carolyn Tomei

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    Can everyone please read the earlier comments before posting your own comment?

    Representative Tomei's comments:

    10:23 a.m. "Hi KatSwing, Thank you for your question. Thank you for your question. My bill, HB2817, would not affect doctors giving out free samples."

    10:47 a.m. "Hi John, I want to assure you that my bill would in no way prohibit or control free samples."

    8:59 p.m. "Alice, There is nothing in HB2817 that would inhibit pharma companies from giving out free samples. Those samples are not what this bill is about."

    Really, people. Let's respect the Representative's time and stop asking questions that have previously been answered.

  • Ron Ledbury (unverified)
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    I cannot find any provisions in the incorporation statutes, including those for non-profits, that allow a doctor in their own name to play the role of a non-profit.

    If a doctor wants to also play the role of non-profit they can create some entity other than themselves to take receipt of samples. The entity can exist to give such samples, gifts, to the public. Such non-profit entity can, because it is a non-profit, and because it is a condition of obtaining such non-profit status for tax purposes, agree to keep their books open for inspection by the Attorney General.

    "Thank you for your question. My bill, HB2817, would not affect doctors giving out free samples. Almost all of us have benefitted from this practice."

    All of us have been harmed by this practice. It is part of a scheme to keep prices higher than they would otherwise be. It is related to effective maintenance of a monopoly. If I had enough private resources or the position of the Attorney General I could either bring a class action on behalf of the poor or charges unfair trade practices against the Doctors, together with big pharmaceutical companies, to remedy the harm to us all from the prices that are carefully kept too high.

    I am an economist and I am used to the idea of looking at things from a net-benefit perspective, and in particular things related to prices and the extraction of monopolistic rent.

    Kari, on January 16, 2004, I remarked about the particularly thorough and grotesque intrusiveness of the DHS's own rules and questions for determining the poorness of citizens so as to get aid from the government. In large measure this is to get aid to cover high prices, the high prices to which I object to as monopolistic. My present link to this earlier whine is here. http://pdxnag.com/drupal/node/312

    Go look at DHS's own page here; and particularly click on item 11 on that page entitled "Counting Client Assets." A poor person that needs care, as a condition of getting that care, must fully splay out their entire set of private resources, at the risk of state criminal charges for fraud and always with the risk of a state demand to return the cost of services provided by the state to cover stuff like high priced drugs, all just to prove their poverty.

    As a genuine advocate for the poor I would say that a focus price, including the dividing line between free sample and monopolistic price, would provide ample opportunity to achieve a net-benefit, in aggregate, to all. Lower prices would allow more people to be covered and reduce the demand for ever more rigid eligibility requirements for public funds that flow like a raging river to big pharmaceutical companies, in the name of the poor.

    Bruce Weber at OSU's Agricultural and Resource Economics department routinely addresses issues of rural poverty in Oregon. I received my undergrad degree in Agricultural and Resource Economics from OSU, though my real curiosity was internationally-related developmental economics. My adviser had said, many years ago, that I could do more good for rural Oregon by going to law school. I would like that to be as true now as then.

    So, Kari, your admonition about excusing and avoiding the issue of free samples falls on deaf ears, from an economic perspective.

    If what you want is a vigorous presentation of the needs of the poor for medical care I can give it to you. What I won't do, or at least try not to do, is suppress analysis so as to isolate on politically targeted attack left or right. What I will do, or at least try to do, is redirect politically targeted attack left or right, toward genuine analysis. I am as much an opportunist as any other.

    The precise wording from HB 2817 of "subsidy or other economic benefit" would squarely include free samples. It would fit conclusively within the statutory construction terminology of "plain meaning," thus avoiding the intricacies noted in the frequently cited case of PGE v. BOLI. The referenced journal article is not inconsistent with the inclusion of free samples too.

    Have I made my case?

    (Billy got intemperate in a past email to me on the issue above regarding the convention center gig, so I have cover in the event he might take personal offense to my reference in the earlier comment. I could make it personal if I wanted, or if I am sufficiently prodded; in the interest of the poor.)

  • humblerodent (unverified)
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    Okay, so let me get this straight. Half the responses to Rep. Tomei's article are worried that if we ask to have some form of transparency in the shady practices of free trips to Hawaii and fancy dinners - we'll end up scaring big PhRMA away from giving out free samples or opening a manufacturing plant in Oregon?

    Gifts create a relationship and can also create an obligation which can also create a need to reciprocate. In the end these companies and their reps are mainly peddling influence and market share - not free drugs for low income patients and the uninsured (again HB2817, would not affect doctors giving out free samples). A 4-day trip to Hawaii might end up making you more relaxed and refreshed and perhaps even a better doctor when you return, but does that mean that pharmaceutical companies should pay for it?

    I would have thought that Representative Tomei’s article would have been met with a barrage of emails saying" "Go get em' Carolyn!" or "It's about time!"

    Instead we heard:

    "Sure, have them report but be careful not to scare off potential investment and jobs."

    And

    "I am concerned the additional reporting requirements would discourage "small pharma" companies from marketing their emerging products."

    What is going on here!?!?!?

    Pharmaceutical companies and reps have become a filter between the relationship of a doctor and patient. After an individual has seen 50 commercials for some new drug on TV that has urged them to "ask their doctor" - they go into a docs office and are already sold on that drug.

    How can a doctor even begin to "unsell" that patient or recommend an alternative or even a generic brand that in many cases would be an equivalent to the more expensive brand-name drug? It makes it even harder when that doctor has already be detailed over and over again by a drug rep.

    I'll give you my story about free samples:

    I have been in Oregon for quite a few years now and ever since moving here have been victim to seasonal allergies. So I go and see my doctor and the doc says I can try the Flonase since there are some free samples I can have. Instead I asked my doctor if there is an alternative or generic I can use - or can I even just start with a saline solution? There was a generic and I did use it and it worked fine.

    I asked for the alternative because even though some might view the free samples of Flonase given out by the Rx company as a "benefit" - all I could see it as was a way for them to shill out free goodies to increase their market share for that area as well as me (the patient) contributing to the overall problem by just taking the more expensive brand name drug when there was an alternative.

    This next part is taken from www.nofreelunch.org

    "Once a patient is given a sample, there is a good chance that this patient--and other patients--will be prescribed that medication at a later date, even though equally effective (or perhaps more effective, less expensive--and possibly less hazardous--) medications are available. Vioxx (and before Vioxx, Rezulin, Trovan . . .) was heavily sampled and heavily prescribed. Patients would have been better off (and some of them still alive), if they had been prescribed older, safer drugs."

    Now back to my own words...

    Oregon has the Oregon Prescription Drug Program (OPDP) available to see at:

    http://www.oregon.gov/DAS/OHPPR/OPDP/index.shtml

    I remember this year when SB329 (a bill to further expand this current program) was on the Senate floor and Sen. Jeff Kruse said although it was not socialized medicine it was a step in that direction.

    What!?!?

    It was a step in a direction that allowed the State of Oregon to help control the sky-rocketing costs and the negative affect on our budget and overall health care costs. It was a step that allowed the State of Oregon to negotiate with Rx companies for a fair price. It was step that allowed the State of Oregon to provide discounted prices to those 54 and older without prescription drug coverage and give access to more affordable and life saving prescription they didn’t have access to before. It gave negotiating power back to the consumer. Should we have not created this program? Did it scare away big PhRMA from Oregon? No!

    And so I am 100% behind rep. Tomei and HB2817 because bills like this are a step in the right direction to help begin to tackle & cure our health care woes. Is it a panacea? No, but it is a good start. We need other folks in the legislature to stand with her as well, and voters to raise their voices, in order to get this done next session.

  • Tom Civiletti (unverified)
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    I have no opinion on whether HB2817 would effect free drug samples, but I think the bill is a good idea generally. I am in favor of subsidized medications for the poor, ideally under a single-payer healthcare system. I see the value of product samples as a way to make practioners familiar with something new and a way for patients to try a medication.

    However, I agree with Ron Ledbury that using free samples as a sudsidization tool is part of the present system of too-high drug prices in the US. Would banning free samples fix the system? Probably not, but preserving free samples is not a good reason for preserving the federal government mandated price supports for Pharmaceutical companies. We are being gouged by them, and we are being gouged by the health insurance companies. Millions of Americans are paying with their health and lives. The healthcare delivery system in the US needs to change fundamentally and quickly.

  • twinkie (unverified)
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    The last two posts by humblerodent and Tom Civiletti have it exactly right. In the end, the issue is not 'protecting free samples' - it's addressing the need for free samples.

    As long as we continue to accept free marketing materials as a substitute for real, affordable health care for all our citizens, we are going to continue getting free market health care options for some, and a patchwork of charity and subsidized health care for the rest: our most vulnerable elderly, disabled, and young, and the millions of uninsured working poor and low-income Americans.

    When we have people like Jack Abramoff running the tables, legislators like Rep. Tomei are to be commended, rather than cautioned, for trying to bring transparency to this issue.

    And besides - even the most rain-loving Oregonians need a little 'sunshine' every once and awhile.

  • Kit (unverified)
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    The concerns about free pharmaceutical samples bring up another issue I’m not quite seeing addressed: that of using doctors’ poorer patients as guinea pigs for as yet unregulated pharmaceuticals. I also grew up in a family who “benefitted” from our local doctor’s samples. I have now been disabled by multiple chemical sensitivities and related health problems for over 20 years, unable to benefit from most pharmaceutical preparations because of adverse reactions. I wonder how much of my condition can be attributed to samples I received as a child which have since been found to have adverse affects? At this point it’s impossible to trace. This issue is mirrored in the recent controversy over the chemical industry’s practice and proposed furtherance of subjecting poor, neglected/abused, and orphaned children with no proper parental protection to pesticide exposures in order to test the health effects on humans. In general, people in poverty tend to have less education and are obviously more economically desparate. Their relative ignorance and need basically gives carte blanc to those in corporate power to do harm without liability in the name of research, sidestepping accepted regulatory processes with considerably less cost to themselves. Yes, the majority of free samples are intended to create brand recognition; yes, the majority of funding of medical schools and medical journals comes from pharmaceutical companies, which necessarily creates obligation; yes, similar obligation for "gifts" is found in the political arena; and yes, the health care system in this country needs a major overhaul, especially with respect to those in poverty. To do something about it, first steps are needed.

    I think Carolyn’s bill is a great first step to educating the general public about the pharmaceutical and medical systems’ practices, which have gone too long in questionable secrecy. Only with education can we be proactive in keeping ourselves safe from those who place profit above health and well-being. Thank you, Carolyn.

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