Monday, June 28, 2010

Another hero of the anti-vaccine movement bites the dust

Boyd Haley is a retired professor of chemistry from the University of Kentucky. His name has appeared several times in the Comments sections of this blog , when commenters have presented him as a scientific expert supporting the claim that thimerosal in vaccines causes autism.
In his own words, Haley has said
“I have been a strong proponent of investigating thimerosal as the casual agent for autism spectrum disorders based on the biological science that shows thimerosal to be incredibly toxic, especially to infants.”
Haley also wrote
“If, indeed, the complete removal of thimerosal from vaccines was not followed in an appropriate time by a decrease in autism then this would be solid proof that thimerosal was not causal for autism.”
Thimerosal was removed from childhood vaccines in the U.S. by 2002, and the rate of autism diagnoses continued to increase, but Haley simply changed his tune and continued to claim that thimerosal causes autism. The overwhelming (and still growing) evidence against the thimerosal-autism link has apparently done nothing to change his mind.
Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?
Well, he does: money.
As Chicago Tribune reporter Trine Tsouderos wrote in a two-part storythis past week, Haley and his company have been marketing a chelating agent – a powerful, highly toxic chemical that removes mercury from the bloodstream – as a treatment for autism. They also claim that this chemical, called OSR#1, is a harmless dietary supplement. Haley’s company, CTI Science, is selling OSR#1 as "a toxicity free, lipid soluble antioxidant dietary supplement." The Tribune ordered 30 100-milligram capsules of OSR#1 for $60 through an online pharmacy.
The FDA has sent Haley and his company a formal warning letter telling them to stop marketing this unapproved drug as a supplement. Haley’s claim that OSR#1 is a supplement is a flimsy attempt to try to avoid regulation of this potentially dangerous chemical as a drug, though it clearly is a drug. (Dietary supplements are unregulated in the U.S. - a topic for another day.) The FDA letter is unambiguous, stating:
“this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.”
Just to be sure, I checked the CTI website today, and the main headline is “CTI Science Introduces OSR#1.” Haley is President and CEO of the company and his former University of Kentucky holds a patent on it. There are no clinical trials or other data showing that OSR#1 is safe or effective; on the contrary, the FDA letter explains that it can have several serious side effects, including diarrhea, abnormalities of the pancreas, and lymphoid hyperplasia.
This hasn’t stopped Boyd Haley and his company from marketing their drug as a treatment for autism. The anti-vaccination site Age of Autismhas promoted it; indeed, the Tribune reported that
[AoA’s] managing editor, Kim Stagliano wrote of sprinkling the white powder on her three daughters' breakfast sandwiches and orange juice. "We've seen some nice 'Wows!' from OSR," she wrote.
Boyd Haley may be misguided, but he has a deep financial reason for pushing the link between thimerosal and autism: without it, his company can’t sell its product.
Will the anti-vaccinationists start to doubt Dr. Haley? Will his obvious conflict of interest, and his violation of FDA regulations, make them wonder why he’s selling them a powerful, possibly harmful chelating agent to treat their children? I hope so.

Technip agrees to pay $338 million in case

Global engineering firm Technip S.A. has agreed to pay $338 million to settle accusations that it engaged in a decade-long scheme to bribe government officials in Nigeria, the Justice Department announced Monday.
The department says the Paris-based company conducted the alleged bribery scheme to obtain more than $6 billion in contracts to build liquified natural gas facilities.
Technip chairman and CEO Thierry Pilenko said the agreement with U.S. authorities "puts this legacy story behind us and enables us to focus on continuing to develop Technip's business."
Technip was part of a four-company joint venture that included U.S. firm Kellogg Brown & Root Inc. The government of Nigeria awarded four contracts to the venture from 1995 to 2004.
Under the settlement, Technip has agreed to pay a $240 million criminal penalty and the Justice Department has filed a deferred prosecution agreement and a criminal information resolving charges of conspiracy and of violating the Foreign Corrupt Practices Act.
The company will pay $98 million to settle a related civil complaint by the Securities and Exchange Commission.
Technip authorized the hiring of two agents to pay bribes to Nigerian government officials, according to court papers in the case.