At the House Appropriations Committee hearing on the NIH Budget, NIH director Dr. Francis Collins was grilled about the collusion between the NIAAA and the alcohol industry in planning a clinical trial to study the health benefits of alcohol use. Congresswomen Lucille Roybal-Allard (D-CA) expressed concern about the fact that NIAAA violated NIH policy by soliciting funding from the alcohol companies and asked Dr. Collins who authorized the solicitation of funding. While Dr. Collins did not answer the question, he did say that his office is conducting an investigation and will provide the Inspector General with any uncovered materials that are of concern.
The questioning begins at 51:30 of the video.
Thursday, April 12, 2018
Sunday, April 08, 2018
Principal Investigator of Alcohol Clinical Trial is Hiding its Industry Funding from the Public and Potential Research Subjects
I have already explained why I think the Moderate Alcohol and Cardiovascular Health (MACH15) clinical trial should be immediately halted because of both scientific and ethical breaches in the way the research was planned. Today, I reveal what I believe is misconduct in the actual conduct of the trial: namely, in the communication of the research sponsors to the public.
I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.
The Rest of the Story
On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.
Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.
This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.
The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.
I believe that the public -- and especially research subjects -- have the right to know who is funding a clinical trial that is seeking their participation. In fact, there are rules requiring the sponsors of such studies to be revealed to the public. However, I believe the MACH15 study is violating these principles by hiding its true sponsors from the public.
The Rest of the Story
On the study web site, the study sponsor is reported as being the "National Institute on Alcohol Abuse and Alcoholism (NIAAA)." However, nowhere on the site does it disclose that the real sponsor behind the research are alcohol companies, which have ponied up to cover two-thirds of the cost of the entire research project. The alcohol money is being funneled through a "middle man" (the NIH Foundation) on its way to NIAAA, but the source of the money is clear: this is an alcohol industry-funded study. In violation of ethical principles for the conduct of research, this critical information is not being disclosed to the public on the project web site.
Therefore, I am calling both the Department of Health and Human Services (through the Inspector General) and Congressional oversight committees to require the study researchers to disclose to the public and potential participants that this study is being funded by the alcohol industry.
This is too reminiscent of the unethical behavior of tobacco-funded researchers in the past who failed to disclose the industry funding of their research. In fact, it was this behavior that contributed heavily to the implementation of conflict of interest disclosure rules.
The rest of the story is that the principal investigator of the MACH15 trial is hiding from the public the fact that this is an industry-funded study. I believe the trial should be halted, but if it is allowed to continue, the researchers should be forced to disclose the industry funding to the public and to any potential research participants.
Sunday, April 01, 2018
Alcohol Clinical Trial Should be Halted Because It Was Designed to Promote Drinking, Not to Answer a Research Question
Digging Deeper into the Harvard/NIAAA Solicitation of Alcohol Company Funding
In a previous post, I noted that I had reviewed materials obtained by the New York Times and shared with me for the article revealing that the NIAAA solicited funding from alcohol companies for the clinical trial of potential benefits of alcohol. A deeper examination of those materials allows me to now reveal that the real purpose of the clinical trial is not to conduct research to answer a question, but to help the alcohol industry sell beer, wine, and liquor by producing newspaper headlines to get doctors to start recommending moderate drinking to their patients.
The document I reviewed is a slide presentation and accompanying summary information apparently intended for a sales pitch to alcohol companies to fund this clinical trial. According to the New York Times: "two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014." The lead scientist on the "presentation team" was Dr. Kenneth Mukamal, who is now the Principal Investigator of the clinical trial. The senior federal health official on the "presentation team" was Dr. Lorraine Gunzerath, the Senior Advisor to the Director of the NIAAA.
Importantly, according to the New York Times, Dr. Gunzerath stated that this research would not have been conducted without the support of the alcohol companies because "We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly."
Based on this information, it appears that we already have three areas of misconduct in this research study before the trial itself has even been initiated:
1. The NIAAA violated NIH policy by soliciting funding from the alcohol industry. The NIH policy does not allow institutes to solicit funding. (NIH Policy Manual 1135 [Gifts Administration] - "NIH policy prohibits employees, either directly or through another party, from requesting or suggesting donations to the NIH or to any of its components, of funds or other resources intended to support activities.")
2. The NIAAA also violated NIH policy by accepting funding for a study that would not have been conducted were it not for the alcohol company money. Institutes of the NIH may accept a contribution, but only to conduct research that is either already underway or that would have been conducted even in the absence of that contribution. (NIH Policy Manual 1135 [Gifts Administration] - "the NIH may accept a gift to support a mission-related priority if it is already conducting the activity or is prepared to conduct the activity even without the gift. However, the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities.")
3. The trial's principal investigator appears to have lied about not knowing that alcohol companies were supporting the trial and "literally" not having had any contact with alcohol companies.
The Rest of the Story
These facts alone are sufficient to warrant an immediate halt to the clinical trial. But today, I am revealing that the story gets even worse.
The stated purpose of the clinical trial, according to the presentation materials, was not to conduct an impartial investigation into the health effects of moderate drinking, but to produce newspaper headlines that would get doctors to recommend that their patients start drinking. Here is how the primary aim of the research was described:
"The proposed clinical trial is designed to provide doctors with the scientific/medical justification to incorporate a moderate drinking recommendation into their advice to patients."
To execute the sales pitch, the presentation includes a slide entitled "The Ultimate Goal." What is the ultimate goal? The slide shows three newspaper headlines touting the health benefits of an olive oil diet and a Mediterranean diet. Apparently, the ultimate goal is to generate news headlines reporting that moderate drinking is part of a health diet.
In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."
Yet another slide emphasizes that "What's missing" is "the type of convincing evidence that will show that moderate drinking is: 1) Safe 2) Part of a healthy diet to lower risk of common, important health problems. How do we do that?"
The rest of the story is that beyond even the violation of NIH policies and the ethical breaches committed in the planning of the study, the trial is scientifically compromised from the start because the researchers have essentially promised positive results to the alcohol industry, have demonstrated a substantial bias that undermines the objectivity of the study, and have stated that its purpose is not to answer a research question objectively but to provide the opportunity for newspaper headlines in order to convince doctors to start recommending moderate drinking to their patients.
That's a great sales pitch, and it's no surprise that it worked. If I were running an alcohol company, I would have been in on this marketing investment all the way. That the federal government -- and the nation's leading alcohol research agency to boot -- is offering this marketing opportunity is disillusioning.
In a previous post, I noted that I had reviewed materials obtained by the New York Times and shared with me for the article revealing that the NIAAA solicited funding from alcohol companies for the clinical trial of potential benefits of alcohol. A deeper examination of those materials allows me to now reveal that the real purpose of the clinical trial is not to conduct research to answer a question, but to help the alcohol industry sell beer, wine, and liquor by producing newspaper headlines to get doctors to start recommending moderate drinking to their patients.
The document I reviewed is a slide presentation and accompanying summary information apparently intended for a sales pitch to alcohol companies to fund this clinical trial. According to the New York Times: "two prominent scientists and a senior federal health official pitched the project during a presentation at the luxurious Breakers Hotel in Palm Beach, Fla., in 2014." The lead scientist on the "presentation team" was Dr. Kenneth Mukamal, who is now the Principal Investigator of the clinical trial. The senior federal health official on the "presentation team" was Dr. Lorraine Gunzerath, the Senior Advisor to the Director of the NIAAA.
Importantly, according to the New York Times, Dr. Gunzerath stated that this research would not have been conducted without the support of the alcohol companies because "We were supposed to be preventing alcoholism, so to spend that kind of money on research for a possible good use of alcohol was something that would never fly."
Also, according to a previous New York Times article: "Dr.
Mukamal, who has published dozens of papers on the health benefits of
alcohol consumption, said he was not aware that alcohol companies were
supporting the trial financially. “This
isn’t anything other than a good old-fashioned N.I.H. trial,” he said.
“We have had literally no contact with anyone in the alcohol industry in
the planning of this.”"
Based on this information, it appears that we already have three areas of misconduct in this research study before the trial itself has even been initiated:
1. The NIAAA violated NIH policy by soliciting funding from the alcohol industry. The NIH policy does not allow institutes to solicit funding. (NIH Policy Manual 1135 [Gifts Administration] - "NIH policy prohibits employees, either directly or through another party, from requesting or suggesting donations to the NIH or to any of its components, of funds or other resources intended to support activities.")
2. The NIAAA also violated NIH policy by accepting funding for a study that would not have been conducted were it not for the alcohol company money. Institutes of the NIH may accept a contribution, but only to conduct research that is either already underway or that would have been conducted even in the absence of that contribution. (NIH Policy Manual 1135 [Gifts Administration] - "the NIH may accept a gift to support a mission-related priority if it is already conducting the activity or is prepared to conduct the activity even without the gift. However, the NIH is precluded from accepting a gift to support an activity that would not be conducted but for the gift and thereby reorders the programmatic priorities of the agency and diverts the use of appropriated dollars from activities with higher priorities.")
3. The trial's principal investigator appears to have lied about not knowing that alcohol companies were supporting the trial and "literally" not having had any contact with alcohol companies.
The Rest of the Story
These facts alone are sufficient to warrant an immediate halt to the clinical trial. But today, I am revealing that the story gets even worse.
The stated purpose of the clinical trial, according to the presentation materials, was not to conduct an impartial investigation into the health effects of moderate drinking, but to produce newspaper headlines that would get doctors to recommend that their patients start drinking. Here is how the primary aim of the research was described:
"The proposed clinical trial is designed to provide doctors with the scientific/medical justification to incorporate a moderate drinking recommendation into their advice to patients."
To execute the sales pitch, the presentation includes a slide entitled "The Ultimate Goal." What is the ultimate goal? The slide shows three newspaper headlines touting the health benefits of an olive oil diet and a Mediterranean diet. Apparently, the ultimate goal is to generate news headlines reporting that moderate drinking is part of a health diet.
In another slide, entitled "The Bottom Line," the presentation again explains that the primary purpose for the study is to "convince clinicians, patients, and policymakers that alcohol consumption in moderation is safe and a healthy part of diet..."
Yet another slide emphasizes that "What's missing" is "the type of convincing evidence that will show that moderate drinking is: 1) Safe 2) Part of a healthy diet to lower risk of common, important health problems. How do we do that?"
The rest of the story is that beyond even the violation of NIH policies and the ethical breaches committed in the planning of the study, the trial is scientifically compromised from the start because the researchers have essentially promised positive results to the alcohol industry, have demonstrated a substantial bias that undermines the objectivity of the study, and have stated that its purpose is not to answer a research question objectively but to provide the opportunity for newspaper headlines in order to convince doctors to start recommending moderate drinking to their patients.
That's a great sales pitch, and it's no surprise that it worked. If I were running an alcohol company, I would have been in on this marketing investment all the way. That the federal government -- and the nation's leading alcohol research agency to boot -- is offering this marketing opportunity is disillusioning.
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