Life Science Compliance Update

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October 20, 2008

Wisconsin State Medical Society: Dumping Gifts

This past week the Wisconsin Medical Society passed a voluntary ban on gifts to physicians becoming the first state medical society to enact such a ban.

The ban categorizes gifts as: “Physicians shall accept no gifts from any provider of products that they prescribe to their patients such as personal items, office supplies, food, travel and time costs, or payment for participation in on-line CME. A complete ban eases the burdens of compliance, biased decision making, and patient distrust.”

Could a complete ban be a cop-out for physicians in Wisconsin -- so they don’t have to make choices between right and wrong?   "If our doctors accept nothing then the problem will go away, and our patients will trust us."

In reality, if physicians in Wisconsin will focus on being the best there are with no exceptions, staying current with the literature, patients will trust them. 

The problem is not gifts, which PhRMA and their member companies unilaterally withdrew this summer, it is physicians who are having a hard time adjusting to modern medicine.

Your patients want to know that whatever you are giving or doing to them will help them live better lives, relieve their symptoms and save their lives.

In their list of gifts they mention payment for participation in on-line CME, until this morning I was unaware of this practice, I'm not sure if this refers to certified CME or what.

This policy is strong and clear,” said Society President Steven Bergin, MD. “It leaves no doubt that the Society’s physicians want to prevent even the impression that a gift–no matter how small–could get in the way of a physician’s decision-making.”  (But where is the evidence to back up this decision? Where is the proof of patient harm?)

He also stressed that the policy should not be implied as a condemnation of any specific group or industry.   (Translation:  industry we still want your money, even though we just trashed you to our members and the press.)

This policy simply puts the Wisconsin Medical Society on record that individual physicians should take a bright line approach to accepting items from companies that make products or drugs that the physician might end up prescribing or recommending to his or her patients,”

I am sure you will find this hard to imagine but I am not a fan of gifts, but I think individual physicians should be making this call, not the government or medical society, and often, as we see later in their recommendations, they confuse gifts with medical updates.

 

Dr. Bergin said. “There’s nothing more sacred than the physician-patient relationship, and we physicians have the responsibility to make sure nothing gets in the way of that relationship–or even appears to get in the way.”

 

Actually the most sacred part of that relationship is that what the doctor gives me or does for me helps me in the end.  Or at least to the best of his knowledge, and that he/she is current with the literature on what works best.

 

In the policy they then go on to quote Medical philosophers from ancient to modern affirm the priority of patient interest as the cornerstone of medical professionalism and the first principle in resolving conflict of interest (COI) questions. …   (The ancient medical philosophers also killed most of their patients with unproven therapies, but hey, they practiced the art of medicine.  I am going to stick to science which helps people.  I guess the doctors in Wisconsin are nostalgic, their arguments from here are generally lacking.)

 

The remainder of the document is ad nauseam statements including:

 

High quality patient care and health outcomes depend on patient trust in physician advice.

 

COI is ubiquitous in human relationships, including the patient-physician relationship, therefore, the profession and each physician every day must strive to acknowledge and manage COI in order to prevent avoidable bias in medical decision making. A physician’s prescribing decision should be based on the best evidence available.

The reciprocal giving of gifts is an ancient human practice and likely has survival value by reinforcing social bonds. Health product companies have long offered gifts to physicians and the profession has long denied being influenced by these gifts. By distinguishing among possible gifts according to monetary value or value to patient care, ethicists have attempted to estimate the risk that specific gifts could bias medical decision making -- no doubt these distinctions have reduced the frequency of outrageous gifts, however, it is becoming apparent that any gift from a product provider to a product prescriber risks biased decision making, and at least, risks loss of patient trust in physician advice. Some conflicts can’t be avoided, but avoidance of unnecessary conflicts is the cornerstone strategy of professional conflict management.

 

An article found in JAMA 2006: 295: 429-433 (you read journal articles; you don’t find them) has renewed the western world’s conversation about the commercial relationship between health product industries and the profession of medicine. Following their recommendations, the Society affirms (affirm is not the same as recommend or require) the following examples of ethical professional behavior. (The article they quote is the Brennan paper which earlier this summer, Thomas Stossel, MD pointed out in an Medscape editorial was written with a predisposition to its conclusion and ignored all evidence to the contrary)

                 

The direct provision of drug samples to patients should be limited and, when possible, should be replaced by a system of vouchers for evidence-based drug choices.  (Try that one on the many patients who benefit by short term use of a drug or where you want to see if that drug has an effect.  They will all be clamoring for the extra step of going to the pharmacy to get a one week supply and the pharmacies look forward to all the free prescriptions they will have to fill)

 

Physicians serving on formulary committees who have any kind of commercial relationship with a health product company shall disclose any such relationship and recuse themselves from the formulary process, as necessary to avoid bias.

(This is one of the few Brennan recommendations, I would agree with.)

 

CME providers should not accept support from health product companies directly. A CME provider may create a fund for medical education that may accept unrestricted donations from health product companies that is then dispersed according to institutional policy; this policy, financial contributors and the amount of their contributions shall be disclosed as public information on an easily accessible Web site.   (Just give us the money and we will do something good with it.  Of course no charities, governments, corporations or foundations are foolish enough to just give you the money….)

 

Physicians should not serve as members of speaker bureaus for health product companies or their contractees. (They affirm the Brennan argument that physicians shouldn’t speak on behalf of a product even if they believe it will save the patient’s life or increase their well being; this is utter nonsense.)

 

Physicians should not allow their names to be listed as authors for articles written by health product company employees, a practice called “ghostwriting.”  

(Ghost writing sounds awful, but in many cases the physician researcher may not be the best writer.  Research and education are collaborative efforts and may require a whole team to best analyze a study, so that just one researcher's bias is not presented or written.  Often the peer reviewers are not looking at the raw data, so this extra step of multiple views, i.e. ghost writing, is probably more beneficial than harmful to the enterprise.)

 

Since ethical collaboration between the profession and the health product industry is essential for the continued development of health products, high-integrity consulting and research relationships shall be strongly encouraged.

(This is absolutely correct.  We all need each-other to develop the next best medicines.)

 

However, to avoid such relationships being tantamount to a gift, such relationships shall be based in contracts for specific “deliverables” in return for just compensation. (Everyone wants just compensation, the problem lies when the government decides what that should be)

 

The whole concept of gift bans and pledges like the Wisconsin Medical Society enacted, are based on supposition that only one party (the patient) should benefit from the practice of medicine and all others (physician, manufacturer, hospital, health plan), should have no benefit.

 

The following office sign is available for members of the Wisconsin Medical Society:

 

Office Sign:

 

TO OUR PATIENTS

To uphold the highest standards of our Profession,

To ensure our advice is based solely on what’s best for you, and

To enable your highest level of trust in our advice,

We follow the recommendations of the Wisconsin Medical Society,

And accept no gifts from any provider of a product that we prescribe or recommend to you.

We are offering an alternative sign for offices in Wisconsin:

 

Alternative Office Sign:

 

TO OUR PATIENTS

To uphold the highest standards of our Profession,

To ensure our advice is based on sound scientific evidence and what is best for patients,

To enable your highest level of trust in our advice,

We will do everything in our power to stay current with the latest scientific literature, to discuss scientific topics with as many reliable sources as possible.

Since we are not all knowing, we welcome you pointing out to us any articles that you think may be applicable to your condition.

 

We have also thought about what the sign will be like in the year 2018.

 

Office Sign (Year 2018)


TO OUR PATIENTS

To uphold the highest standards of our profession

To ensure our advice is based solely on information we acquired twenty years ago.

So you won’t have trust in our advice anyway

We follow at the detriment to ourselves, families and community the recommendations of the Wisconsin Medical Society

And accept no gifts, no payment for services or other compensation whatsoever. 

If you feel led please leave a few dollars by the door on your way out, and please excuse our lack of staff and lights, for without compensation those are not necessary.

Please let the Wisconsin Medical Society know you appreciate the free service.

 Starting next week we will be practicing in a shack, five miles down the road.

If you are with the student loan company or others looking for payment please disregard the previous sentence.

 

 

Wisconsin Medical Society:  Gift Ban

Wisconsin Medical Society: Press Release

Wisconsin Medical Society: Home Page

Medscape Editorial: Response to AMA's Council on Ethical and Judicial Affairs Draft Report on "Ethical Guidance for Physicians and the Profession With Respect to Industry Support for Professional Education in Medicine"

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I recently came across your blog and have been reading along. I thought I would leave my first comment. I don't know what to say except that I have enjoyed reading. Nice blog. I will keep visiting this blog very often.


Deborah

http://termlifeinsurance2.com

"Just give us the money and we will do something good with it. Of course no charities, governments, corporations or foundations are foolish enough to just give you the money…"

No charities or foundations do give money with the post-facto intention of selling you something afterward, so their shareholders (and execs) can enrich themselves.

Let's make an effort to stay honest here.

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