Thursday, December 11, 2008

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.


Supremacy Claus said...

Dan: Post your income tax return, and each 1099 form for 2007. I want to see if you have any conflict of interest.

Anonymous said...

Please do the same. I want to see if you have any common sense.

Anonymous said...

SC, I find it interesting & scary that you don't think you should have to follow the rules. As I'm sure you're aware there are rules requiring disclosure of financial COI when you're doing research, unless perhaps you work at some no name institution. I really think you should share your views with your institution's IRB.

Anonymous said...

Published on

The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list of corruptive tactics by the pharmaceutical industry that sponsors such trials. By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and as sterile and aseptic as possible- completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated. This is particularly a factor on post-marketing studies of various pharmaceutical companies because others seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind. Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past. Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research.
This resulted in the creation of for-profit research trial sites called Contract Research Organizations that are often composed of primarily community patient care clinics absent of any research training compared with the former researcher that existed decades ago. Because of this structure, investigators of these pharmaceutical sponsored trials are likely void by sponsor design of necessary research experience or quality regarding their research purpose and ability to ensure authenticity if not ethics. This, of course, happens with intent by the sponsor who can control the trial protocol much more at these locations. These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied. . Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this protocol of the sponsor ensures favorable results of the sponsor’s medication after the trial is complete. Their activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor; as such sites are largely unregulated.
Guest authorship has been known to be aggressively recruited by sponsors and usually the sponsors seek investigators to be recruited for this function in addition to being the lead investigator of their fabricated clinical trial. The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor. The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company and also acts as the publisher, manuscript version reviewe,r and trial director who works with their drug company’s hired CRO editors whose objectives are to benefit the sponsor, it has been reported. Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO exceeds 1000 dollars per page, some have said. Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits. Apparently, this is no longer the case.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may agree to pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent and replaced with what could be harmful to others.
More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement of the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.
“Ethics and Science need to shake hands.” ……. Richard Cabot
Dan Abshear
Author’s note: What has been written was based upon information and belief.

The Observer said...

The Department of Public Health seems to maintain the kind of policies that give an edge to private sector profits instead of the health, safety and welfare of Massachusetts citizens. This is not necessarily an overt unethical decision but rather a reflection of the lack of vision and an unwillingness to commit to new preventive polices. Transparency is a good thing but DPH policy makers and management generally respond to new ideas as members of a culture committed to sustaining what they know.

Approaching DPH with formal or informal proposals that are outside of their direct experience are usually received with, “We can’t do that.” The bottom-line is, they are not problem solvers, are consistently unwilling to take a strong stance if it is unpopular or risky and are resistant to collaborating and sharing information with other state and federal agencies. The state is full of energetic, smart, committed, innovative people but their talent is lost under an inflexible leadership.

The resistance within the Department of Public Health can be described as the kind of thinking that is easy versus right. Many people encounter the groupthink that serves to obstruct solutions. It will be hard to decrease health care cost and improve public health if we are unwilling to confront conflict of interest. After what we have witnessed, especially in the past few months, why can’t DPH see the real human and economic costs of conflict of interest?

If policy makers continue to allow the for profit private sector to influence public policy then we have no chance of decreasing health care costs or ensuring ethical conduct, free from conflict of interest. Why DPH even considered the impact public health policies have on whether a pharmaceutical company obtains information about another, which is basically about trade secrets, is a complete unknown. Apparently the DPH leadership considers conflict of interest less significant to public health then industry trade secrets or perhaps it is more likely the leadership lost sight of their mandate and caved under the pressure of really smart, really persuasive, highly motivated lobbyists from the pharmaceutical industry. If that is the case, isn’t it time to replace DPH officials with some new really smart, really persuasive, highly motivated public health advocates?

Meaningful health care reform will never happen unless the state and federal government is filled with people willing to try something new. I can’t find any Massachusetts public health officials who are willing to be the architects and carpenters of health care reform. I’m not sure I see the kind of people who really want to be part of something special. Many public health professionals would be excited and honored to participate in the historic impact of reforming health care in Massachusetts and the country. Right now, we have people who lack the vision to even notice that the country is watching how Massachusetts manages universal health care. The country just observed DPH public policy leaders once again tolerate conflict of interest in our health care system. Even with Governor Patrick’s leadership, which opened the door, the Massachusetts Department of Public Health decided to continue the policies that have defined the era of conflict of interest, consequences and all. The reason they did this; it’s what they know.

Supremacy Claus said...

Rules should remedy a harm. In the absence of a demonstrable harm, a rule is oppression, and a form of lawyer rent seeking, a witch hunt, and bad faith.

Do you believe that carbon dioxide contributes to global warming? The US Supreme Court agrees. It made it subject to regulation by the EPA. Every time you exhale, you are being a polluter. I suggest you report yourself to the EPA and DOJ for dumping of carbon dioxide into the air.

Rules are just made up by lawyer. They have no external validation. Show me the data on the harm that will be attenuated by obeying the rules discussed here. Otherwise, get off the back of the doctor.

Anonymous said...

Hey SC:
Rules, Schmules. Where are your tax returns and 1099's? Are you going to post them soon? Or, are you just dumping carbon dioxide in the air (and on this blog)?