Gottlieb, Scott dr

===

TRUMP FDA HEAD?!

rev door, DOUBLE DIPPER! did not walk talk on tobacco and opioids

TROY?

off bs bio features CBS and aei logo

Scott Gottlieb, MD, is a resident fellow at the American Enterprise Institute. From 2017 to 2019 he served as the 23rd commissioner of the Food and Drug Administration. Dr. Gottlieb is also a special partner with the venture capital firm New Enterprise Associates and serves on the boards of Pfizer, Illumina, Aetion, and Tempus.

In addition to his frequent testimonies before Congress, Dr. Gottlieb is often published and interviewed by the media. He is a regular guest on Face The Nation and a contributor to CNBC, and his commentary and articles have appeared in Health Affairs, The Wall Street Journal, The Washington Post, and The New York Times, among other outlets.

https://www.scoop.co.nz/stories/HL0708/S00239/fda-henchmen-protect-avandia-profits.htm

no lnx

...Evelyn Pringle

The FDA's latest campaign to protect the profits of a drug company over the safety of Americans is unprecedented, and the organizers include a gang of current and former FDA officials largely credited with turning the nation's regulatory beagle into a lapdog for Big Pharma under the Bush Administration.

FDA spokesman Douglas Arbesfeld, apparently the industry's new inside guy, kicked off the campaign by sending an e-mail to journalists which was intended to discredit Dr Steven Nissen and the Cleveland Clinic. Dr Nissen's study appeared online on May 21, 2007, in the New England Journal of Medicine and warned that GlaxoSmithKline's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%.

The talking points for the media appear to have been formulated and agreed upon ahead of time between Arbesfeld and others (see below) because more than one story from ostensibly different sources later appeared in the media and on the internet referring toDr Nissen with such names as "St Steven", "Patron Saint of Drug Safety" and "Saint Steven the Pure."

In his email to journalists, Mr Arbesfeld pasted portions of an article which appeared on the Heartwire website, containing umpteen critical comments about Dr Nissen and the Avandia study, as well as comments made by an anonymous blogger on the internet who said that business at the Cleveland Clinic is run similar to a Mafia TV series. The full bog states:

"Wake up pharmaceutical companies, this is a call from Dr. Nissen, if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company."

"The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano's — the Clinico's 'next week who should we wack ......' — Bata bing bata boon. Comment by Brian A - May 22, 2007."

However, it could just as easily be inferred that Mr Arbesfeld authored the slanderous blog and supplied it to Heartwirewith the intention of quoting it later from a “reputable” web site. For its part, Heartwire has since removed what it says are "unsubstantiated remarks about Dr Nissen and the Cleveland Clinic," and states: "In retrospect we regret that we published those sentences, as they do not meet the highest standards of journalistic or scientific integrity or credibility."

The smear campaign has federal lawmakers up in arms. At a June 6, 2007 hearing before the House Oversight and Government Reform Committee, in response to questions about Mr Arbesfeld sending the e-mail under his official title of FDA spokesman, FDA Commissioner Andrew von Eschenbach told the lawmakers, "It was an inappropriate and unfortunate act on the part of an individual which has been addressed through disciplinary procedures."

Dr Nissen is none too happy about the stunt either. "I'm a pretty tough guy," he told ABC News on May 30, 2007, "but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."

As for his part, Mr Arbesfeld told the Boston Globe that the email reflected his own personal views and not the FDA's. Any assertion that the email reflected his own personal views is not quite credible considering that his previous employment was always promoting the views of the industry.

A few articles in the media mentioned thatMr Arbesfeld worked for Johnson & Johnson, but his employment with public relations firm Manning Selvage & Lee was not noted. On December 16, 1999, the Healthcare Marketing & Communications Council reported that Mr Arbesfeld had joined Manning as Senior Vice President in New York.

On January 5, 2001, the firm issued a press release to announce the promotion of Mr Arbesfeld and others and referred to Manning as "one of the largest healthcare practices worldwide and has a broad array of clients including Allergan, Amgen, Eli Lilly and Company, Genentech, Hoffmann La-Roche, Kaiser Permanente, Novartis, Pharmacia and Procter & Gamble."

In reading the press release, Mr Arbesfeld's expertise with using the Internet is apparently a bi-product of his work for Manning. "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."

On August 5, 2002, Arbesfeld identified himself in a Reuters article as representing none other than Glaxo,along with six other drug giants including Bristol-Myers, Aventis, J&J, AstraZeneca, Abbott Labs and Novartis, in a campaign to promote the "Together Rx" prescription drug card program for senior citizens. In 2005, the Reporters Handbook listed him as the contact person for J&J subsidiaries, Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.

Less than a week after Mr Arbesfeld's hatchet job on Dr Nissen, ex-FDA Deputy Commissioner Dr Scott Gottlieb planted an editorial in the May 29, 2007, Wall Street Journal entitled, "Journalist Malpractice," accusing the New England Medical Journal of intentionally publishing the Nissen study to make the FDA look impotent. "The publication was timed," he wrote, "to get ahead of the Food and Drug Administration's more careful evaluation of the same issues."

"The journal seemed bent on beating the FDA to the punch," Dr Gottlieb claimed.

"The goal?" he said, "Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals."

The only problem with the Nissen-NEJM conspiracy theory is that the issue under investigation in Congress right now is why the FDA did not warn the public about Avandia heart risks six months before the Nissen study was ever published.

In the end, when it comes to "Journalistic Malpractice," the larger question would seem to be how was it that so many industry shills were able to get the major media outlets and medical journals to immediately publish commentaries and editorials attacking the NEJM and the Nissen research with headlines splashing all over the internet.

In his editorial, Dr Gottlieb notes that there are "questions" whether Avandia is associated with heart risks, but says they are "so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world."

"When it comes to the issue du jour, drug safety," he wrote, "no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval."

Assuming this is true, the problem is that the industry insiders running the FDA refuse to act on the advice of the agency's top scientists with first hand access to the underlying data. In a July 26, 2007 speech on the Senate floor, Senator Charles Grassley (R-Iowa), of the Senate Finance Committee, said that, in the case of Avandia, "Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent."

In the past two months, he told his fellow senators, "I've had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia."

The Heartwire website conveniently echoed Dr Gottlieb's sentiments by featuring portions of a May 23, 2007, unsigned editorial from the medical journal The Lancet, which claimed that the verdict on Avandia should await the results of a Glaxo sponsored trial called RECORD, not due out until 2009.

"Taken together," the editorial said of Dr Nissen's findings, "these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information about rosiglitazone's safety."

"But the FDA, physicians, and patients can reasonably await the results of RECORD, a phase 3 trial designed specifically to study cardiovascular outcomes," it said.

"Until the results of RECORD are in," the Lancet noted, "it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses."

The problem with waiting two years for the results of the RECORD trial is that FDA scientist Dr David Graham reviewed the results of this study thus far and told an FDA advisory panel that the study design is so flawed that the results should not be considered in any risk benefit analysis of Avandia now, or in 2009.

In fact, Dr Graham says the RECORD study is so useless that it is probably unethical to allow it to continue because no possible benefit can be achieved by allowing it to go on and that Avandia should be pulled off the market now because thousands of patients are being injured each month by using the drug.

At the end of his editorial, Dr Gottlieb lists himself as a physician and a resident fellow at the American Enterprise Institute, as well as former Deputy Commissioner of the FDA from 2005 to 2007. However, back on August 24, 2005, the Seattle Times provided a much better picture of his background and highlighted the oddity of the FDA hiring him in the first place in light of his solid alliance with the industry. "Only a month ago," the article states, "Dr Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors."

At the time, the Times noted, "Now Gottlieb holds the No. 2 job at the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted."

"Now, as one of three deputy commissioners," the article said, "Gottlieb will help oversee such major policies as the FDA's fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry."

The Times also noted that a half-dozen current and former FDA officials said they did not know of anyone else from Wall Street ever moving directly into such a high-level job at the agency.

A couple months later, the November 12, 2005, Boston Globe reported that Dr Gottlieb could not participate in formulating the nation's defense plan against the avian flu due to conflicts of interest. He "was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic," it said. Yes, the very same Manning Selvage & Lee at which Arbesfeld held the Senior Vice President position. Does anyone smell a rat (or several)?

The article pointed out that Dr Gottlieb's former clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the parent company of the nation's sole flu vaccine maker.

According to the Globe, Manning paid Gottlieb a $12,500 monthly retainer for nine months for projects that included eight companies, and he was also paid $9,000 for private consulting work for VanGen Inc, a firm that won a $878-million contract to supply the US government with 75 million doses of anthrax vaccine.

Dr Nissen and Dr Gottlieb's disputes are not new. In fact, on August 2, 2006, they participated in a debate on the topic: "Government Science Panels: Fair and Balanced?" sponsored by the Center for Science in the Public Interest, and reported on byRussell Mokhiber and Robert Weissman in Common Dreams.

Likewise, lawmakers have mentioned in their communications with the FDA that they found it "troubling" that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because they were on opposite sides regarding the approval of the heart failure drug Natrecor.

Much to his credit, Dr Nissen openly communicated his objections to the industry's infiltration of the FDA. While sitting right next to Dr Gottlieb, he candidly described the conflicts of interest, which he stated were "evident at the highest levels of the FDA."

"For years," he said of FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."

"Then the administration appointed Andrew von Eschenbach as interim commissioner creating another conflict," he said. "In his role as director of the National Cancer Institute, von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict," he noted.

"But even worse," Dr Nissen stated, "the administration appointed Scott Gottlieb as deputy commissioner."

"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter," Dr Nissen told the audience.

Dr Gottlieb's response to Dr Nissen's comments was, in essence, that he would not dignify the comments with a response.

Firms with which Dr Gottlieb was involved prior to his gig at the FDA, according to the Globe, also include the Inamed Corp, one of two companies that were seeking to return silicone gel implants to the market and on November 17, 2006, the FDA announced that it would lift restrictions on the sale of the implants.

When Dr Gottlieb left the FDA, he headed right back to greener pastures with the drug giant Novartis. The press release to announce his hiring read: "Bench International Places Eminent Regulatory Advisor Scott Gottlieb, M.D., as Senior Counsel to Novartis."

"Under an exclusive consulting agreement," the release stated, "Scott Gottlieb, M.D., will provide advisory services to Novartis on matters of global regulatory policy and strategy."

Two more members of FDA’s alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as the anonymous blogger, likewise referring to Dr. Nissen as a “self-appointed and media-anointed Patron Saint of Drug Safety” and “Saint Steven the Pure.”

For much of the childish commentary, they poke fun at Dr Nissen because he acknowledged in the NEJM that he consults for many drug companies but said he "requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction."

At the end of the commentary, Mr Pitts says he is a former FDA associate commissioner, and both men list their affiliation with the Center for Medicine in the Public Interest; but as usual, that listing really does not give credit where credit is due.

On its web site, the Center describes itself as "a non-partisan, non-profit educational charity," and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It's a breeding ground for industry moles preparing to enter "public service" and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA's Associate Commissioner from 2002 to 2004 as serving as the agency's "Chief Messaging Officer."

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: "I know Doug Arbesfeld and he is a guy devoted to advancing the public health."

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

"He is also a guy," Mr Pitts says, "who took a pretty significant pay cut to put in some time in public service."

Some would no doubt argue that it's difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts' sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg's bio also says he used to be Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the "Godfather of Preemption," sits on this "charity's" Advisory Board.

Troy’s bio points out that he "played a principal role in FDA’s generally successful assertion of preemption in selected product liability cases."

This "assertion of preemption" says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product's serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he's switched back to private practice, Mr Troy's CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with "particular focus" on what else - clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called "Patient-Centric and Prospective Medicine," CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, "former Medicare administrator and FDA commissioner, will chair the group."

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration's FDA can find it right in the middle of cyberspace on the CMPI web site.

Persons seeking legal advice regarding Avandia can contact Baum, Hedlund, Aristei, Goldman & Menzies Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

http://www.avandia-heart-lawyers.com/.

*************

Evelyn Pringle

evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)

(This article is part of the Avandia Update series sponsored by the Baum Hedlund law firm)

~ wsj (some post vioxx?]

Journalistic Malpractice, or Pharmaceutical Malpractice?

In today's Wall Street Journal, Scott Gottlieb of the American Enterprise Institute has a piece entitled "Journalistic Malpractice" that accuses medical journals such as the NEJM of an ideological agenda and demonization of the pharmaceutical industry.:{ The piece can be read in its entirety at the AEI website at this link.

The "money quote" is this:

At what cost do political machinations of the medical journals come? When editors pursue a political agenda, it's public health that pays a price ... There is a problem when some journals let antipathy for business interests and left-leaning views interfere with the medical decisions that they make, bending standards or stepping outside their mandate, using their prestige and influence in ways that distort medical facts in the aim of influencing political outcomes.

I have written a letter to the editor to the WSJ in reply. As its chances for publication are slim (the WSJ published my letter to the editor regarding electronic medical information privacy in Dec. 2006 and will be unlikely to take another one so soon), I have reproduced my response below:

May 29, 2007

Re: "Journalistic Malpractice" (WSJ, Tue May 29, 2007, p. A15)

Dear WSJ,

In “Journalistic Malpractice” (WSJ, Tue May 29, 2007, p. A15), Scott Gottlieb writes that medical journals such as the NEJM are pursuing a political agenda of left-leaning views and seems to imply some journals are demonizing the pharmaceutical industry.

I think he’s missed the root cause of the attacks on the pharmaceutical industry almost entirely.

The root cause is not primarily the result of an ideological or anti-capitalist agenda; after all, both the left and the right and everyone in between get ill, and stand to benefit from pharmaceutical innovation.

:{

The cause of the attacks from venerable journals such as the NEJM is not ideology, but mistrust . The pharmaceutical industry has taken societal trust - a must for any industry to be successful - and blown it out of the water. In fact, the public mistrust of the pharmaceutical industry has been well-earned.}:

As many print and web-based writers including the Foundation for Integrity and Responsibility in Medicine (FIRM) have increasingly and repeatedly pointed out in websites such as FIRM's Healthcare Renewal ( http://hcrenewal.blogspot.com), where I occasionally write on medical informatics-related topics, pharma has regularized some highly questionable practices.

It is an industry that hires ghost writers to “pave the road” for new or existing drugs with what amounts to scientific spin doctoring. It bribes clinicians with gifts and perks. It advertises its wares shamelessly, as if it were selling lingerie. It presents data “with the best foot put forward” until forced not to, and has done this in some exceptionally socially-tender areas, such as antidepressants in children regarding suicidal ideation.:{ It is an industry that hires MBA-credentialed senior executives who never took care of a patient in their lives (one of the largest pharma's CEOs was actually general counsel at McDonald’sand was president of the company’s smaller brand, Boston Market), leading to clinician and patient disgust and distrust. Its websites promise employees wonderful careers helping people, and then the industry lays off thousands of such professionals in a heartbeat due to a slight tick in stock market valuations. It is an industry where R&D may be controlled by non-medical personnel who often have more power to control internal information flow and availability than senior scientific leadership. (I've seen IT departments effectively running R&D through rationing of critical drug discovery tools.)

In effect, pharma is an industry that socially acts like a bull in a china shop. My only surprise is that the medical journals are not even more hostile than they already are -- and that may have to do with "money issues" as in the preceding paragraph.

Put bluntly, the pharmaceutical industry has lost the public trust. It is said that self-improvement cannot come before one has insight into one’s faults.

Blaming medical journals for journalistic malpractice while the pharmaceutical industry commits social, medical and scientific malpractice is mistaking a symptom for its causative and far more society-damaging disease.

-- SS

Addendum: I am informed of the following via "Integrity in Science Watch - May 29, 2007" (link) in its "Cheers and Jeers" section:

Jeer: To the Wall Street Journal for failing to tell readers of an op-ed by Scott Gottlieb, former FDA deputy commissioner now at the American Enterprise Institute, that AEI takes financial contributions from the drug industry and former Merck chief executive Raymond V. Gilmartin sits on its board. The op-ed accused the New England Journal of Medicine of "journalistic malpractice" in publishing a study that suggested the diabetes drug Avandia, made by GlaxoSmithKline, increased the risk of heart attacks.

I am a Medical Informaticist who gotlaid off by Merck under Gilmartin's watch during the "Equinox" mass layoff of 4,400 people in Nov. 2003(they name the layoffs...) This was after helping fill a huge gap in flow of scientific articles to Merck scientists from a constant 100K/year from 1989 to 2000, to over 1,000,000 per year by 2004, and ending rationing of essential drug research informatics tools due to (non-scientist) IT personnel's control of the budget. I accomplished those feats through aggressive challenging of the "IT-department-controls-research" status quo, probably making me a prime layoff target.

I received a special benefit: I gained experience in how to lay off people, because as a manager I was made to take the layoff training in the days before they laid us off. Good industry social graces indeed.

With regard to my post above and the "Cheers and Jeers" item, I say this:

"I rest my case."

-- SS

see scott gottleib

https://www.ucsusa.org/resources/glaxosmithkline-tried-silence-scientist-who-exposed-dangers-its-drug-avandia

oct 2017

when Dr. John Buse found that a diabetes drug had the side effect of higher risk of heart disease, GlaxoSmithKline officials threatened his integrity and career.

In July 2010, an FDA advisory committee recommended a recall of Avandia, a drug used to treat Type-2 diabetes, and placed severe restrictions on its availability. GlaxoSmithKline, Avandia’s manufacturer, had long known about the drug’s potentially life-threatening side effects. But the company used its power to silence scientists rather than protecting its customers by bringing the harm to light.

A decade earlier, in 1999, Dr. John Buse at the University of North Carolina found that Avandia users had a high risk of heart disease, and published his findings. In response, Buse alleges, a representative from the company contacted his boss, accused him of lying, and threatened to sue him for a $4 billion drop in the company’s stock valuation.

A Senate Finance Committee report confirmed Buse’s charges, revealing that a GlaxoSmithKline official emailed Tadataka Yamada, then the company’s chairman of research and development, urging him to write a “firm letter” to Buse. It would contain a warning that “the punishment will be that we will complain up his academic line and to the CME [continuing medical education] granting bodies that accredit his activities.” Yamada wrote back, “I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well-planned offensive on behalf of Avandia.” Yamada also called Fred Sparling, the chairman of Buse's department at UNC, and communicated the threat of lawsuits.

After this blatant harassment, Buse felt he had no choice but to sign a letter drafted by the company which walked back his scientific findings. It stated that his comments on the drug “had been taken out of context” and that “only years of use, greater patient exposure and comparative clinical trials” would provide the data needed to allow any drug “into proper perspective.” The letter was used by the industry to persuade financial analysts to change their safety assessment of Avandia, which resulted in its staying on the market another decade.

In 2007, a meta-analysis of 42 randomized controlled trials of the drug confirmed Buse’s findings and revealed that there was a 43 percent increase in the risk of heart disease among diabetics taking Avandia. When questioned on its intimidation of Buse by the Senate Finance Committee in 2007, GlaxoSmithKline released a statement saying, “perhaps we could have handled interactions with Dr. Buse better,” but otherwise denied that it had retaliated against the scientist. After reviewing extensive documents from Buse, the Committee concluded that the behavior of the company was “troubling” and “had Buse been able to continue voicing his concerns, without being characterized as a ‘renegade’ and without the need to sign a ‘retraction letter,’ it appears that the public good would have been better served.”

Ultimately, this case—including the ultimate corroboration of Buse’s findings—spawned thousands of lawsuits charging that GlaxoSmithKline’s handling of the drug caused death and illness in patients. The company has already paid at least $90 million to settle some of them.

trump and his FDA commissioner ‘grossly misrepresented’ data on blood plasma’s benefits in treating COVID-19 patients: scientists

Alex Henderson

A recurring theme during the opening night of the 2020 Republican National Convention was that President Donald Trump saved hundreds of thousands of American lives because of his quick and…

https://www.alternet.org/2019/07/warren-calls-for-immediate-resignation-of-trumps-former-fda-chief-after-he-quietly-joins-pfizer-board/

**Warren calls for immediate resignation of Trump’s former FDA chief after he quietly joins Pfizer board**Ma:{ybe **Scott Gottlieb** thought he could avoid scrutiny by making the move to the board of pharmaceutical giant Pfizer just over two months after leaving his position as President Donald Trump’s commissioner of the U.S. Food and Drug Administration—but if so, he didn’t count on Sen. Elizabeth Warren.:(style="background-color:#ffffff;"):}:

Warren, a Democrat from Massachusetts who is also running for her party’s nomination for president in 2020, released a letter (pdf) Tuesday morning calling on Gottlieb to step down from the board in the name of government ethics.

"You will be on the board of a company that has billions of dollars at stake in the decisions made by the agency you used to head and the employees you used to lead,” states Warren’s letter.

It’s a profitable venture for Gottlieb.

“According to Pfizer,” Warren notes, “board members in 2018 were paid $142,500 in cash retainers, plus received $192,500 worth of Pfizer stock.”

00:0200:33

Appointed by Trump, Gottlieb was the head of the FDA from 2017 until he resigned on April 5 of this year. After leaving the government, he took a job with right-wing think tank The American Enterprise Institute. The move to Pfizer, however, came later and was only announced on June 27.

In Warren’s letter, which Common Dreams obtained exclusively and is reproduced below, the senator refers favorably to Gottlieb’s work with the FDA before hitting him on joining Pfizer and tying that move to the behavior of other officials in President Donald Trump’s White House who have left the administration for big money payouts.

“You are the second high-level Trump Administration official in less than two months to join the board of a corporation soon after leaving government service,” reads the letter. “In May 2019, former Trump Administration DHS Secretary and Chief of Staff John Kelly joined the board of Caliburn, Inc., the parent company of the Comprehensive Health Services, which runs the notorious Homestead Temporary Shelter for Unaccompanied Children in Florida.”

“You should rectify your mistake and immediately resign from your position as a Pfizer board member,” Warren adds.

Warren’s letter cites her Anti-Corruption and Public Integrity Act as a possible solution to government officials behaving in this way in the future. As Common Dreamsreported in June, Warren and the legislation’s sponsor in the House, Rep. Pramila Jayapal (D-Wash.), see the problem as systemic to Washington’s public-private revolving door. Rep. John Sabarnes (D-Md.) is co-sponsoring Jayapal’s version of the law.

Gottlieb’s move to Pfizer was also noticed by Public Citizen Health Research Group co-founder Sidney Wolfe.

“This is classic and it’s not surprising,” Wolfe told health news site Stat. “Philosophically, he’s returning to the ecosystem where he’s most comfortable. And he’ll get paid very well for it, too.”

Read Warren’s letter:

Sen. Elizabeth Warren’s… by on Scribd

https://kpfa.org/episode/the-ralph-nader-radio-hour-april-8-2019/

IV drug abused by docs visuva sufetynyl more potent, dod for war --> small pill

public citizen petition

500x more powerful than morphine, but not useful for war 11/2/18 fda commissioner doubt

https://www.opensecrets.org/news/2017/04/fda-nominee-gottlieb/

This week, all the attention’s on Judge Neil Gorsuch, President Donald Trump‘s nominee to become an associate justice of the U.S. Supreme Court.

But there’s another position in play: Tomorrow (April 5), the Senate Committee on Health, Education, Labor and Pensions will hold a confirmation hearing for Scott Gottlieb, who’s in line to head the Food and Drug Administration.

It would be a return trip to the agency for Gottlieb, who was a deputy commissioner under President George W. Bush. Gottlieb, whose stance is relatively deregulatory, wrote in 2012 that “a few key structural reforms” could improve the FDA’s “counterproductive” culture. He also wrote about the agency’s “cumbersome [drug] approval process,” which dovetails with Trump’s description of the FDA as “slow and burdensome” — though many note that the U.S. drug approval process is already the speediest in the world.

But Gottlieb has held posts that could please people on both sides of the aisle. He’s worked at FDA in two other capacities, besides being deputy commissioner, and he’s been a clinical assistant professor at New York University’s School of Medicine since 2011.

More controversial is Gottlieb’s history of working with pharmaceutical companies. According to his personal financial disclosure, Gottlieb has been on the boards of directors of eight pharmaceutical companies and one laboratory company, and is still on the board of four of them. He’s also a member of the product investment board at GlaxoSmithKline, the world’s sixth-largest public pharmaceutical company.

Gottlieb’s non-board positions in health-related companies have also been numerous, from serving as acting CEO and director of Cell BioTherapy, Inc., an animal medicine company, to being a venture partner at New Enterprise Associates, a venture capital firm that invests in technology and health care companies.

Gottlieb’s work history

Critics believe that appointing Gottlieb, a fellow at the conservative American Enterprise Institute since 2007, would invite conflicts of interest and other ethics troubles.

“The major problem is that he has deeply-rooted ties to big pharma that span more than a decade,” said Michael Carome, director of Public Citizen’s Health Research Group. “His ties include receiving hundreds of thousands of dollars in payments to be a consultant and a speaker; he’s a venture partner at a venture capitalist company that funds multiple large and small companies that do work on biopharmaceuticals and medical devices; and he is someone who in addition to being entangled with multiple industry ties, he’s advocated for a dangerous deregulatory approach to the review of medications.”

The pharmaceutical industry has rewarded Gottlieb well. Over the past 12 months, GlaxoSmithKline paid him more than $87,000, and Daichii Sankyo U.S. sent over $52,000 his way. Tolero Pharmaceuticals paid him $35,000, and he exercised and sold another $193,111 in Tolero stock options.

For more information, including sources of income exceeding $5,000 per year (lots of speaking gigs there) and employment agreements and arrangements that Gottlieb had in the past 12 months, check out his personal finance disclosure statement.

For his part, Gottlieb, in his ethics agreement, says that for a period of one year, he’ll recuse himself from FDA decisions involving the companies where he currently holds positions. That year-long firewall would begin as soon as he resigns from the firms. A similar recusal would apply to his consulting clients, but the one-year period would be retroactive to the last date he did work for them. For companies in which he has financial interest, like Collective Health and Golden State Medical, the recusal would last until he divests his stock — but would apply only to issues that, to Gottlieb’s knowledge, have “direct and predictable effect[s] on the financial interests” of the organizations.

Carome’s not convinced that those recusals will suffice. “The letter basically affirmed what we already knew: That he’s entangled in a wide web of financial conflicts of interests. No amount of recusal will disentangle himself from all those conflicts of interests,” he said. “He’s going to be involved in decisions that will impact the bottom line of these companies for years.”

Alternatively, Paul S. Ryan, vice president of policy and litigation at Common Cause, acknowledged that Gottlieb’s plan of recusal and divestment fits the bill of what’s expected of federal employees. “It sounds like he’s doing the right thing, the required thing, when he divests from the pharmaceutical companies,” he said.

But Ryan also raised Gottlieb’s potential to return to work in the pharmaceutical industry after having overseen it. Trump’s executive order on ethics restricts how soon a govenment official can take a job lobbying for an organization; Gottlieb’s case is different, Ryan said. “[W]e’re talking about going to work at a company and getting a big paycheck after having done things to benefit that company during your time as a federal employee.” That situation’s not unique to Gottlieb, of course.

James Shehan, head of the FDA regulatory practice at Lowenstein Sandler, is more heartened by than worried about Gottlieb’s background. Regarding what some perceive as potential conflicts of interest, Shehan said, “To me, it’s indicative that he’s familiar with a lot of the issues that are relevant to FDA because he’s been continuously involved with them for many years. And I kind of expect him to be a good FDA commissioner.”

“To me, the question is never does someone have a potential conflict of interest — it’s how do you deal with it,” he added.

Here are the organizations listed in Gottlieb’s ethics letter, with the recusal terms for each of them.

Gottlieb’s Senate confirmation hearing is scheduled to begin at 10 a.m. tomorrow, April 5.

Avandia controversy

Following Dr. Steven Nissen's publication of a study warning that "GlaxoSmithKline's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%," he was publicly pilloried. "More than one story from ostensibly different sources" derisively referred to him as "St Steven," the "Patron Saint of Drug Safety," and "Saint Steven the Pure," reported Evelyn Pringle in an August of 2007 CounterPunch article.^[14]

Among the Nissen attackers was Food and Drug Administration (FDA) spokesman Douglas Arbesfeld. Arbesfeld previously worked for the public relations firm Manning Selvage & Lee (MS&L), helping Glaxo and other "healthcare clients maximize internet-relations." Former FDA Deputy Commissioner Dr. Scott Gottlieb, who ridiculed Nissen in a Wall Street Journal editorial, also consulted for pharmaceutical companies at MS&L. Two more FDA alums, Peter Pitts and Robert Goldberg, mocked Nissen in a Washington Times piece. Pitts is the senior vice-president for global health affairs at MS&L. Goldberg doesn't have ties to the PR firm, but serves with Pitts as an officer of the Center for Medicine in the Public Interest (CMPI), which Pringle describes as a "nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA."^[15]

CMPI is a project of the**Pacific Research Institute**, a free market**think tank**.