In May 2007, FDA spokesperson Douglas Arbesfeld made headlines when he waged a smear campaign against cardiologist Dr Steve Nissen, after his study in the New England Journal of Medicine showed the diabetes drug Avandia, sold by GlaxoSmithKline, increased the risk of heart attacks by 43% and cardiovascular deaths by possibly 64%.
Mr Arbesfeld used his official FDA email account to send messages to reporters with derogatory comments about Dr Nissen and his employer, the Cleveland Clinic, with quotes from an anonymous blogger who basically said they were out to get Glaxo because Glaxo does not fund research at the Clinic and that the conduct of Dr Nissen and the Clinic was similar to that seen on the Sopranos, a TV series about a Mafia crime family.
Mr Arbesfeld's stunt caught the attention of the US House Committee on Oversight and Government Reform, which was already investigating the FDA's role in failing to inform the public about the increased cardiac risks of Avandia. At a June 6, 2007, hearing, FDA Commissioner von Eschenbach acknowledged that the emails had been sent but said Mr Arbesfeld had not acted on behalf of FDA.
He told the Committee that this was an inappropriate action by an individual, not an action by the FDA or the FDA press office, and that Mr Arbesfeld had been reprimanded with a letter in his employment file.
The next day, a bipartisan group of lawmakers from two congressional committees sent a joint letter to the Commissioner asking him to explain the agency's policy on conflicts of interest regarding hiring persons like Mr Arbesfeld who recently worked for drug companies directly regulated by the FDA and to explain the need for the use of tax dollars to pay for a communications consultant.
The Committee found it even more troubling, the letter said, that Mr Arbesfeld might be using his position to settle old scores with Dr Nissen, "since the two have been on opposing sides of drug safety in the past."
As an example, the lawmakers cited an April 26, 2005, New York Times article that reported quotes by Dr Nissen that were critical of J&J's drug Natrecor and noted that Dr Nissen cast the only vote against the drug when an FDA advisory panel recommended its approval in 2001.
"The person featured in the article defending Natrecor," they wrote, "was Mr Arbesfeld, who at the time was Johnson & Johnson's spokesman."
The letter was signed by Senators Chuck Grassley, Max Baucus and Sherrod Brown and House Representatives John Dingell and Bart Stupak.
In a press release to announce the investigation, Senator Grassley said, "After all the talk of reform by the FDA commissioner, it's discouraging and alarming to see another situation where you can't tell the difference between the actions of the FDA and those that might come from a drug maker it's regulating."
"I have some serious questions about Mr. Arbesfeld's use of government resources," Senator Baucus stated, "but I am even more concerned about whether his drug company connections led him, in any way, to seek to unjustly discredit Dr. Nissen."
"The FDA should thank doctors who identify potential health risks, not demonize them," Senator Brown said. "Congress is working on legislation to clean up FDA's act, and none too soon."
In the press release, the lawmakers described Mr Arbesfeld as an "FDA spokesman, who previously worked for multiple pharmaceutical companies," and noted that his previous disagreement with Dr Nissen was when he was a spokesperson for J&J.
When reporting the story about the smear campaign, a few articles in the media also mentioned that Mr Arbesfeld previously worked for J&J, but his employment with Manning Selvage & Lee was not noted.
Back in 1999, Mr Arbesfeld was a senior vice-president at Manning, according to a December 16, 1999, press release by Healthcare Marketing & Communications.
On January 5, 2001, a Manning press release announced his promotion to national director of e-Health, and listed the firm's clients to include: Amgen, Eli Lilly, Genentech, Hoffmann La-Roche, Novartis and Pharmacia.
His emailing expertise was likely honed during this gig with Manning. The firm's press release said that, due to the increased growth in the e-health category, Mr Arbesfeld would be concentrating full time as national director of e-Health.
"In this role," it said, "Arbesfeld will help healthcare clients maximize internet-relations in the marketing and communications mix, and will expand the practice's strategic e-product offerings."
By August 2002, Mr Arbesfeld was hard at work trying to get senior citizens to enroll in a prescription drug card program called, "Together Rx," on behalf of seven drug makers, including Avandia maker GlaxoSmithKline, according to Reuters on August 5, 2002.
In what was described as "a splashy press event," the Together Rx program was launched in April 2002, as a single-card program that claimed to give discounts to seniors in the range from 20% to 40% on medications.
According to Reuters, full-page ads appeared in 13 major newspapers and letters announcing the program were mailed to 735,000 doctors.
At the time, Mr Arbesfeld said a 5-city enrollment event involving local government officials and senior centers was planned for the fall, with likely locations to include Cleveland, Phoenix and Memphis, Tennessee. "We're looking for places where there's a good percentage of our target audience," he told Reuters.
In a little over a month of operation, he said, there were 118,000 people enrolled, and as of August 1, 2002, the count was 140,000, with thousands more being added each week, and that the sponsors were "pleased so far" with enrollment.
While he would not disclose the marketing budget for the program, Mr Arbesfeld did tell Reuters that the drug companies "really are committed to making this program work and signing up as many people as possible."
Critics told Reuters the program was nothing more than a PR campaign to overshadow the increased prescription drug costs. "I think they're trying to mitigate some of the public relations damage they've experienced in the wake of rising drug prices," said Ron Pollack, executive director of Families USA.
He explained that the discounts would not mean much in the long run because the drug companies would just raise the drug prices to cover any discount. "We have been saying all along, the underlying price increases will dwarf the discounts," he told Reuters.
Dr Sidney Wolfe, director of Public Citizen's Health Research Group, called the offers by the drug companies' card program "a charade of discounts."
In June 2005, Pharmacy Times listed Mr Arbesfeld as executive director of public affairs for Global Pharmaceutical Communications at Johnson & Johnson Pharmaceutical Services, and the 2005 Reporters Handbook listed him as the person to contact for Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.
Tens of thousands of lawsuits are currently pending against Mr Arbesfeld's long list of former employers, most of which accuse the drug giants of illegally influencing doctors to use their product for conditions not approved by the FDA while concealing their often lethal side effects. In many instances, the Bush Administration's FDA, stacked with industry insiders, stands accused of colluding with the industry to allow the rampant off-label use of the products while keeping the dangers hidden.
In this country, doctors are allowed use drugs and medical devices that are approved for one indication to treat another condition, even if the FDA has denied approval for a specific condition. Although it's illegal for a drug company to directly promote a product for an off-label use, in recent years, the drug giants have orchestrated doctor-backed marketing schemes that have turned a long line of drugs and medical devices approved for very limited uses into billion-dollar blockbusters.
As for Mr Arbesfeld's last employer, J&J is mired in litigation involving private citizens, Medicaid programs, shareholders and state and federal law enforcement agencies, as the result of the company's off-label marketing of the atypical antipsychotic Risperdal, the Duragesic narcotic pain patch, the heart drug Natrecor, the anemia drug Procrit, the Topamax anti-epilepsy medication and the Ortho-Evra birth control patch.
The company is also accused of promoting the off-label implants of medical devices for profit such as the Cypher drug-eluting stent and the Charite artificial spinal disc.
On March 1, 2007, US Representative Henry Waxman (D-CA), the chairman of the House Oversight and Government Reform Committee, opened another investigation of the research and marketing practices related to medical devices and drugs made by J&J, as well as Boston Scientific, Eli Lilly, AstraZeneca and Cephalon.
A little over a year ago, in June 2006, J&J received a subpoena from the US Justice Department requesting documents related to the manufacture and sale of the company's orthopedic devices, and search warrants were executed in connection with the investigation, according to J&J's SEC filing on August 8, 2006.
The latest investigation by the feds was revealed in a press release on March 12, 2007, that said J&J had received greetings in the form of 3 separate subpoenas from US Attorneys' Offices in Philadelphia, Boston and San Francisco.
The subpoenas relate to ongoing investigations of the sales and marketing by Janssen for Risperdal, Ortho-McNeil for Topamax, and Scios for Natrecor, all being J&J subsidiaries.
"The subpoenas," the press release said, "request information regarding Johnson & Johnson's corporate supervision and oversight of these three subsidiaries, including their sales and marketing of these drugs."
In the years before he went to work at the FDA, Mr Arbesfeld was very active in the media, defending his former employers at every turn when it came to the off-label marketing of products. However, at this stage of the game, it's easy to see why a mole in the FDA who can funnel information to the industry about all the latest developments in the government investigations would be far more useful than a civilian cheerleader in media.
By Evelyn Pringle
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