Friday, August 1, 2008

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!


Anonymous said...

Too bad. You seem a bit mis-informed. I'm sure your heart is in the right place. Drug companies typically only allow for unrestricted educational grants and as such have no influence as to content or even presenters at these events. Gifts are a thing of the past. Arrogance needs to be balanced with common sense. No physician can be expected to internalize all information available on all disease states within a specialty (let's not forget general practice). I don't know too many physicians that are so insecure as to rely on the input of a representative to discern the value of a particular peer reviewed journal article. That said, the FDA and internal legal departments approve each and every peice of promotional material.

Anonymous said...

Pharmaceutical Industry Exposed: The Desire For An Ethical Resurrection

If you have been in a doctor’s office, you’ve probably seen them. They are the ones that are unusually well dressed — considering their environment. They also are typically young, healthy, and attractive. And worst of all is that they typically pay absolutely no attention to you, the patient, as you are not their objective. Certainly, they will avoid any conversation with you as the reasons for your visits are in opposition.
They are the drug representatives… the detailers… the pharmaceutical promoters and marketers that could care less, really, about your concerns while you are both sharing the same space at the same time. Yet these reps will possibly take up the valuable time of the very doctor you are suppose to see for a health issue or concern, possibly of a serious nature. So there is actually one thing in common between the rep and the patient in the office: you both want to see the doctor, but for entirely different reasons.
Pharmaceutical marketing tactics have become more transparent to many others over the years, and their methods have been exposed more so than they have in the past, yet this transparency and disclosure is rather incomplete. Yet what others have heard or read displeases many, and this information is valid and authentic. This is in large part why the pharmaceutical industry’s image has been traumatized so much during this time over the past decade or so in particular, and the trauma is deserved, considering what the industry does and has done over the years with deliberate intent and reckless disregard in some cases, by seeming to disregard or not focus on patient benefits in order to acquire large and immediate profits.
Yet there are those who are trying to change things for the better. Because pharmaceutical marketers who attempt to influence both doctors and patients is a troubling public heath issue, as they are a threat to the health of the community. Certain advocacy groups such as National Physician’s Alliance,,, or Community Catalyst, among others, are addressing concerns raised by the marketing tactics of the pharmaceutical industry, and their passion and ability to organize and work as a team appears obvious. I think very highly of their continued efforts to improve the well-being of others. Yet much still needs to be done to halt the efforts of the pharmaceutical industry and their tactics they are implementing presently that seem to atrophy the restoration of the health of others.
In a way, such advocacy groups are in fact treating a disease, if one defines a disease as being harmful or abnormal. It’s a corruptive disease designed to benefit the host. Such groups are attempting to prevent disease by atrophy of the etiology of this marketing disease that affects the pharmaceutical industry..
In this article, I address four factors focused on by some advocacy groups and performed by pharmaceutical companies that are trying to be fixed or eliminated by these groups and others, yet the cure will not be immediate:
1. Data mining
Data mining is the process of providing pharmaceutical representatives with historical physician prescribing data specifically related to their promoted products, as well as the volume of prescriptions such doctors have written. This data, while provided to the reps by the employers, is due to the American Medical Association selling this data to the industry, and the association makes around 40 million dollars to do so. This association sells data necessary to identify prescribers’ prescribing habits. The data the reps have from this arrangement allows them to analyze the historical prescribing habits of the doctors they are trying to influence to prescribe the drugs they aggressively promote in order to specifically create the most effective message to a particular doctor based in large part on this prescribing data. It has been stated and known that vicious debates have occurred between pharmaceutical representatives and doctors because of this, if a doctor discovers that they have possession of this data. Furthermore, this data allows the representatives and their employers to identify supporters of their products, which leads to inducing such doctors with consulting fees, as well as developing them into what are known as key opinion leaders in order to speak and consult to other doctors for large fees paid to them by certain pharmaceutical companies. Conversely, other physicians that are not favored by a pharmaceutical company are denied any resources or educational material by a particular pharmaceutical company as well.
There are those that insist this data is necessary for pharmaceutical companies in order to improve the treatment regimens and protocols for the patents the doctor sees, and state the data is useful for such educational purposes for the doctor. This clearly is a fallacy, and is confirmed by the author who never used this data in the ten years as a pharmaceutical representative.
Advocacy groups and others are trying assertively to have bills passed through the legislature in order to prevent pharmaceutical companies from having this data, as it is not fair for the doctors for pharmaceutical companies and their representatives to have such records of their prescribing habits with the prescriptions they write, although the names of their patients are fortunately not included. In fact, pharmaceutical representatives should have no right to possess such data, as it may potentially cloud the objective judgment of the doctor.
2. Disclosure
Others to some degree have received and reported some level of acknowledgment of the money given out by the pharmaceutical industry to those who can potentially benefit the profitability of the pharmaceutical industry dispensing with such inducements, which include the industry’s lobbying efforts. Yet most of their collaborations, remunerations, inducements, and other forms of gifting to the medical establishment remains overall a mystery to the public and the government to a degree until a pharmaceutical company is discovered by the department of justice for this type of wrongdoing. Of course, such bribery is an attempt to establish reciprocity and form mutualistic relationships with those that are bought by a pharmaceutical company. Intimidation and extortion are possibilities as well after such an exchange occurs absent of the speculated results of the bribing pharmaceutical company. This information has been exposed by those very few insiders who are driven to make others aware of such activities because of their concern for others who may be negatively affected by such behavior. These exceptional insiders are known as whistleblowers.
Whistleblowers have been a big help with revealing and uncovering a large part of such activities, which is a rather courageous and brave thing for them to do, considering what they risk. They believe the public health should remain intact, and therefore believe others should know about such activities of pharmaceutical companies to ensure the health of others will be restored, if needed.
Legislation and bills are being contemplated that would mandate pharmaceutical companies to disclose what they dispense financially and for what reasons the money goes where it may. The pharmaceutical industry is the most lucrative industry that exists, so they have the money, yet presently, no one knows where exactly it goes. It is mysterious. And likely, if it ends up that the pharmaceutical industry reports their financial output, it will likely be an exercise in creative accounting for them, as they are unlikely to be obedient with this directive.
The pharmaceutical industry is a rather secretive industry to others. Revelation is quite a threat to them, so it seems. Is it due to cronyism, their concern? Are they some sort of unique cult? One can only speculate.
3. Direct-to-consumer (DTC) marketing
Two countries allow this: the US and New Zealand. Here’s the problem: About a third of those who view such ads seek out their doctor and ask for the advertised medication- regardless if they need it or not. Likely they will get it, if they demand this medication. And the ads are unmonitored until flaws with the ads are discovered and reported. Only then will the ads be addressed by the regulators of the industry. If a discrepancy is discovered, it’s after an ad has been broadcasted, usually for a lengthy period of time. Embellishments with DTC ads are obvious. Exaggerations with the disease states are apparent as well. Elimination of such ads are presently being debated, and many believe they should be entirely eliminated from being shown to consumers. The pharmaceutical industry believes such ads encourage others to seek treatment for what they believe are disease states that exist. Yet they are unable to determine who needs treatment, so anyone is a potential user of an advertised medication. Doctors decide such issues, and not profitable corporations..
4. SafeRx Act
Finally there is the SafeRx Act, being considered by lawmakers now. This act aims to have reps certified by the government in order to be employed and act as pharmaceutical representatives. The certification would or should include more training on the disease states, treatments, and medicines the representatives will be involved with as an employee. This Act is being introducted because most reps have minimal medical training or a medical background because, in the United states, pharmaceutical representatives are chosen more for their looks and personality than anything clinical they could offer. This, needless to say, can be damaging in this particular industry. Yet the act is still pending on a national level. The pharmaceutical industry states that it is a waste of time because they train their representatives… sell and bribe, and not to educate others.
Yet I still honestly recognize the benefits this industry and all that it has provided to others from a historical perspective of lifesaving drugs as well as other medications that delay the progression of chronic diseases. Their effort is acknowledged. And I applaud their efforts to improve patient health when this occurs, and wish for a return of such ethics more than such occurrences happen presently. Needless to say, there are several more issues that need to be addressed with the pharmaceutical industry besides what has been written in this article, but at least some things are being acted on to benefit public health.
Maybe in time the pharmaceutical industry will become more pragmatic if the public is more empowered with knowledge. Doctors should not have any interference from the pharmaceutical industry as it exists today when it comes to the treatment of their patients. I suppose the issue is best summed up by Hippocrates, who said:

“Whenever a doctor cannot do good, he must be kept from doing harm.”

Dan Abshear

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