WSJ baselessly attacked Time for launching "politically motivated attack" on FDA official


A September 27 Wall Street Journal editorial (subscription required) baselessly accused Time magazine of engaging in a "politically motivated attack" on Scott Gottlieb, the Food and Drug Administration's (FDA) deputy commissioner for medical and scientific affairs. According to the Journal, an October 3 Time article investigating possible "cronyism" within the Bush administration "fingered Dr. Gottlieb this week without offering any evidence of any special connections to the White House -- family or otherwise." The Journal went on to "guess" that "Time got suckered by sources who don't agree with Dr. Gottlieb on policy and used the magazine to try to damage his career." In fact, Time did offer evidence that Gottlieb might not be ideally suited to his position at the FDA and also provided evidence of his "special connection" to the Bush administration: Gottlieb once had extensive ties to the pharmaceutical industry, and he is friends with former FDA commissioner Mark McClellan, brother of White House press secretary Scott McClellan.

The October 3 Time article, titled "How many more Mike Browns are out there?" noted that Brown, who resigned as director of the Federal Emergency Management Agency following the sluggish federal response to the Hurricane Katrina disaster, "was discovered to have more expertise about the rules of Arabian horse competition than about the management of a catastrophe," and that "[t]he Brown debacle has raised pointed questions about whether political connections, not qualifications, have helped an unusually high number of Bush appointees land vitally important jobs in the Federal Government." One of the appointees Time spotlighted was Gottlieb -- a former resident fellow at the conservative American Enterprise Institute who, at one time, had "quite extensive" financial connections to the pharmaceutical industry. According to Time: "Nowhere in the federal bureaucracy is it more important to insulate government experts from the influences of politics and special interests" than at the FDA. Time suggested that Gottlieb's impartiality may be tempered by his connections to drug companies.

From the October 3 Time article:

Would he ever be involved in determining whether an individual drug should be on the market? "Of course not," Gottlieb told TIME. "Not only wouldn't I be involved in that ... But I would not be in a situation where I would be adjudicating the scientific or medical expertise of the [FDA] on a review matter. That's not my role. It's not my expertise. We defer to the career staff to make scientific and medical decisions."

Behind the scenes, however, Gottlieb has shown an interest in precisely those kinds of deliberations. One instance took place on Sept. 15, when the FDA decided to stop the trial of a drug for multiple sclerosis during which three people had developed an unusual disorder in which their bodies eliminated their blood platelets and one died of intracerebral bleeding as a result. In an e-mail obtained by TIME, Gottlieb speculated that the complication might have been the result of the disease and not the drug. "Just seems like an overreaction to place a clinical hold" on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication "seems very clearly a drug-related event." Two days prior, when word broke that the FDA had sent a "non-approvable" letter to Pfizer Inc., formally rejecting its Oporia drug for osteoporosis, senior officials at the FDA's Center for Drug Evaluation and Research received copies of an e-mail from Gottlieb expressing his surprise that what he thought would be a routine approval had been turned down. Gottlieb asked for an explanation.

Time also noted that critics including Donald Kennedy, FDA commissioner during the Carter presidency, consider Gottlieb a deviation from the typical high-level FDA appointee, "who are generally career FDA scientists or experts well known in their field." According to Kennedy: "The appointment comes out of nowhere. I've never seen anything like that."

As a possible explanation for Gottlieb's appointment to a government position for which he may not be ideally suited, Time highlighted his "special connection" to the Bush administration in a box story separate from the text of the article. The box story appears in the print version of Time and in the version reproduced on Nexis, but not in the online version of the article. The text of Gottlieb's box story reads:

WHO IS HE? SCOTT GOTTLIEB -- A 33-year-old doctor, Gottlieb handicapped health stocks and blogged as before returning to the Food and Drug Administration in July. In the past, he has been a fierce critic of the agency he now helps run, complaining that it is too slow to approve new medicines and too quick to issue warnings about drugs on the market.

WHOM DOES HE KNOW? As a fellow at the conservative American Enterprise Institute, Gottlieb befriended future FDA chief Mark McLellan [sic], left, brother of White House spokesman Scott McLellan [sic].

WHAT DOES HE DO? As deputy commissioner for medical and scientific affairs, Gottlieb crafts broad policies, such as designing ways to improve doctor-patient communication.

Mark McClellan also served in the White House as senior policy director for health care and related economic issues from 2001 to 2002. The Journal editorial criticized Time for "largely ignor[ing]" Gottlieb's experience working under Mark McClellan at the FDA in 2004.

From the September 27 Wall Street Journal editorial:

Which brings us to the politically motivated attack on FDA Deputy Commissioner Scott Gottlieb -- one of the fellow forward thinkers Dr. [interim FDA director Andrew C. von] Eschenbach will find at the agency. In its zeal to find more "cronyism" in the Bush Administration, Time fingered Dr. Gottlieb this week without offering any evidence of any special connections to the White House -- family or otherwise.

Time seems bothered that Dr. Gottlieb is young and recently worked in the private sector part-time as editor of a medical technology newsletter. Largely ignored by Time is Dr. Gottlieb's previous experience in a substantial policy-making FDA role under Dr. McClellan. Dr. Gottlieb is also one of the few senior FDA officials who still practices medicine, which has kept him attuned to the latest in best practice and to the needs of patients.

The Time piece is "irresponsible journalism," says Frank Burroughs of the Abigail Alliance for Better Access to Developmental Drugs. "Dr. Gottlieb has tried to bring much needed scientific modernization to the FDA and responsiveness to the needs of seriously ill patients." Our guess is that Time got suckered by sources who don't agree with Dr. Gottlieb on policy and used the magazine to try to damage his career.

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