Trump’s FDA Pick Linked to Genentech Lobbyist “Scandal”
Donald Trump’s Pick to lead the FDA, Dr. Scott Gottlieb, has raised eyebrows with his connections to various Pharma and Biotech companies. His video taped interviews, policy papers for a conservative think tank and stock picks (yes, he was a stock picker for Forbes) also provide a strange picture of an anti-FDA pick for the FDA. His outspoken rants against Obamacare provide an even more interesting piece of information in the Scott Gottlieb puzzle. However, his link to reportedly one of the biggest lobbying scandals since Jack Abramoff, may spur the Senate, and President Trump himself to reconsider Scott Gottlieb as the future Commisioner of the FDA.
The Genentech Lobbyist “Scandal”
In February, the Wall Street Journal published Brody Mullins’ amazing story of the life and tragic death of Genentech Vice President Evan Morris. Morris was the VP of government affairs of the Swiss-Owned company and company lobbyist. He was also one of the most connected persons in Washington D.C. and seemed to have been incredibly effective for the company, according to Mullins’ story.
In his story above, and also in a CSPAN interview, Mullins outlined instances where Morris’ lobbying efforts may have been instrumenal in helping to deliver $hundreds of millions in profits to Genentech and their Swiss parent Roche. Arguably, these profits may have been earned through political influence, delivering questionable benefit to U.S. patients. The tactics of Genentech’s Morris outlined by Mullins include the use of the following:
- Use of Think Tanks to Influence Politicians
2. Use of PR Firms to Influence Politicians
3. Using Political Influence to Influence the FDA
Apparently, Morris may have even fabricated receipts according to Mullins’ article for nefarious reasons. Below is an example of one of these receipts provided in the WSJ article…Notice the name of the Think Tank!!! — American Enterprise Institute
Guess who has worked at the American Enterprise Institute???
Trump’s Pick for the FDA is Linked to All of These Tactics
A Senate Committee voted today to approve Trump’s Gottlieb to lead the FDA. Scott Gottlieb’s business with Genentech/Roche and his own words, directly link him to the tactics used by Evan Morris. Was Gottlieb just one of Morris’ Think Tank or PR Firm minions? Was he a powerful puppet placed at the FDA to help a Biotech company thrive under George W. Bush?
The Avian Flu Epidemic, Evan Morris, and $Billions for Roche
According to Mullins, Genentech’s Evan Morris took credit for convincing our nation, under President George W. Bush, to stockpile the Roche drug Tamiflu for the avian flu “epidemic” that never happened. In fact, Tamiflu was stockpiled across the globe to prepare for the avian flu starting around 2005.
According to Mullins, Morris launched his career in 2005 with this opportunity of Tamiflu.
A few dozen people abroad had died after contracting the avian flu, and Americans began to worry about a U.S. outbreak. Mike Leavitt, secretary of Health and Human Services in the Bush administration, said at the time the federal government wasn’t prepared for the threat.
Roche produced the leading treatment, a pill called Tamiflu. Sensing opportunity, Mr. Morris adopted an emerging lobbying tactic: build support among a lawmaker’s constituents to supplement the traditional glad-handing of elected officials with dinners and campaign donations.
Morris needed “consultants” to help create a fear among citizens and politicans regarding the “avian flu epidemic”.
Mr. Morris contracted consultants who promoted news stories that stoked fears about an avian-flu outbreak. The goal was to sell more Tamiflu.
In October 2005, 32 Democratic senators wrote a letter to President George W. Bush expressing their “grave concern that the nation is dangerously unprepared for the serious threat of avian influenza.”
Within weeks, Mr. Bush created an emergency stockpile of avian flu treatments that eventually included more than $1 billion worth of Tamiflu pills. His administration offered subsidies that led to millions of dollars of additional Tamiflu sales to state governments.
We’ll never know if there ever really was a global threat of an avian flu epidemic. Here’s some info about Roche’s drug Tamiflu which has made nearly $18B for Roche.
Trump’s FDA Pick Was a Tamiflu Consultant
What did Roche’s Tamiflu consultants look like? Meet Scott Gottlieb, President Trump’s pick to lead the FDA.
In 2005, Gottlieb was a 32 year old physician, just three years out of his residency in internal medicine. He also picked stocks as a writer for Forbes, wrote for the British Medical Journal, BMJ, and was a fellow at conservative Think Tank, American Enterprise Institute (Yes, the same one on that receipt!). In late 2005, Gottlieb was also picked to be the Deputy Director of the FDA, the top ranking doctor in the entire FDA at the time. Here he is talking about flu pandemic for his Think Tank:
Why Was This Inexperienced Doctor named the Top Physician at the FDA in 2005?
Gottlieb’s appointment to the #2 job at the FDA wasn’t very popular at the time, according to the Seattle Times:
“I’ve never heard of anything like this,” said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.
“If he’s had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It’s fundamental,” Goozner said.
Even a former FDA Commisioner seemed incredulous at the pick of Gottlieb at the time, via TIME:
But others, including Jimmy Carter — era FDA Commissioner Donald Kennedy, a former Stanford University president and now executive editor-in-chief of the journal Science, say Gottlieb breaks the mold of appointees at that level who are generally career FDA scientists or experts well known in their field. “The appointment comes out of nowhere. I’ve never seen anything like that,” says Kennedy.
Gottlieb Wrote a Lot of Articles…For Roche???
So what types of articles did Gottlieb write?
Here’s one article Gottlieb wrote in the BMJ about Bird Flu. This was one of the first articles to describe human to human transmission of avian flu in 2005. According to the CDC’s current website, there is no definitive test to prove human to human transmission of avian flu. However, Gottlieb didn’t seem to care about alarming people.
Here’s an interesting quote from Gottlieb’s article:
Health experts have been worried that the H5N1 virus could one day mutate into a form that passes easily between humans, perhaps leading to a major flu pandemic to rival the Spanish flu of 1918.
Wow, the Spanish Flu of 1918!!! 20–40 Million people died of the Spanish Flu.
Here’s another one from Gottlieb in the same article:
Researchers have confirmed two cases of human to human trans- mission of the avian influenza virus, raising the possibility that the infection could soon gain a foothold among people,with the potential to strike millions.
Gottlieb’s powful alarmism regarding avian flu was actually cited in a research paper discussing the interesting metaphors used to build fear of the Avian Flu. Here’s an example from the article below about how “Flood” and “Tsunami” were terms used to magnify the perceived threat of Avian Flu. It seems that Gottlieb’s article had woken the alarmists!
Scott Gottlieb’s article (in The BMJ) highlights what is now an actual threat to the world’s population. The Tsunami in Asia illustrated one acute natural trauma with thousands of deaths, that catastrophe pales into insignificance when compared with an influenza pandemic (Higson BMJ/letter 2005).
Even one of Gottlieb’s peers, Laura M. Kelly, at his Think Tank, American Enterprise Institute, didn’t seem to buy into his alarmist article:
Fewer than seventy-five deaths from a virus with little or no person-to-person transmissibility have spurred the current wave of pandemic preparedness planning.
Gottlieb Had to Recuse Himself from Avian Flu Planning…then George Bush Awarded Roche a Huge contract
Just a few short months after Gottlieb’s Avian Flu article was published, he earned the FDA Deputy Commissioner role. Almost immediately, he had to recuse himself from Avian Flu planning because of his conflicts of interest with Pharma companies.
In fact, Gottlieb was working for a PR Firm doing “Business Development” for Roche in support of Tamiflu just prior to his new FDA job. Quote from the Boston Globe article above:
Dr. Scott Gottlieb, who joined the FDA as deputy commissioner for medical and scientific affairs, 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. Gottlieb’s former clients include Roche — manufacturer of the highly sought antiviral Tamiflu — and Sanofi-Aventis, parent company of the nation’s sole flu vaccine manufacture.
Gottlieb had a flare for the obvious in his recusal letter:
Gottlieb said a ‘’reasonable person would question my impartiality” in matters related to those firms, according to an Aug. 5 memo to then FDA commissioner Lester Crawford obtained by The Boston Globe through a Freedom of Information Act request.
Here’s the letter he wrote to his boss at the FDA:
and then what happened?
President George W. Bush promised a huge payday for Roche just a few months later according to CNN.com
The plan also calls for spending $1 billion to stockpile antiviral drugs — such as Tamiflu and Relenza — to protect first-responders and $583 million for “pandemic preparedness,” that would include $100 million for states to make plans.
So, almost immediately before he was picked to be the FDA Deputy Director, Gottlieb was getting paid by a PR firm for “Business Development” for Roche’s drug Tamiflu…and he wrote an alarming article for the BMJ without revealing to physicians, researchers, patients, etc, his conflict with Roche.
It gets even worse…Gottlieb was also pumping up Roche/Genentech cancer drugs in his Forbes articles at this time too. In the article below, Scott Gottlieb, despite having no training as an Oncologist, links Roche/ Genentech drugs to “The Cancer Miracle” in his article below.
So just prior to being named the youngest Deputy Director of the FDA ever, Gottlieb wrote articles in favor of Genentech/Roche products. He also admitted to getting paid by a PR Firm for “Business Development” specific to Roche drug Tamiflu. While writing these articles to the public, he didn’t clearly mention this conflict of interest with Roche to his readers. This is the statement of disclosure from the article above:
Dr. Gottlieb may own stock in the companies mentioned in this article or consult with firms that advise them.
This is unbelievable…Inconceivable!!!!
The Gottlieb-Genentech Lobbyist Connection with Avastin
In his Wall Street Journal article about Evan Morris, Mullins reported that Morris “boasted” about delivering $1 Billion in incremental sales to Genentech through his lobbying and PR efforts regarding Avastin for breast cancer.
According to Mullins:
In 2010, the Food and Drug Administration began steps to ban the use of Avastin to treat breast cancer. The FDA had given conditional approval to Avastin — one of Genentech’s top-selling products — but reversed course after the agency said its effectiveness against breast cancer couldn’t be proved, and it posed a greater risk for severe side effects.
Morris had a new goal:
At a cost of nearly $90,000 per patient, Avastin provided the company with $6 billion in sales in 2009, including $1 billion from breast-cancer cases. Mr. Morris set out to stop or stall the FDA.
What types of tactics did Morris use to stall the FDA?
Mr. Morris’s team promoted articles on conservative websites such as RedState, Breitbart News and BigGovernment.com that quoted women in treatment who said the drug was their best chance at recovery.
and Morris reportedly claimed that he was successful:
The FDA reached a final decision more than a year later. In late 2011, the agency rescinded its approval of Avastin to treat breast cancer.
Mr. Morris took credit for orchestrating a delay that, he boasted to colleagues, generated roughly $1 billion in revenue.
Enter Trump’s FDA Pick, Scott Gottlieb with some great articles in defense of Avastin…
Trump’s Gottlieb was a Huge Supporter of Genentech’s Battle with the FDA to Market Avastin for Breast Cancer patients.
Here’s a video library of Gottlieb arguing in favor of the free speech rights of Pharma to discuss off-label drug use with Doctors.
Here’s a Powerful article by Gottlieb in the Wall Street Journal criticizing the FDA’s treatment of Avastin for Breast Cancer. This article was written about a year prior to the final FDA decision. Did this article help Morris in his attempted delay of the FDA decision?
Here’s another article by Gottlieb about Avastin that he wrote for the Think Tank linked to Genentech’s Evan Morris:
The FDA’s decision to strip the drug Avastin of the indication for treating metastatic breast cancer is of a piece with the agency’s aversion to risk — not just the risk of safety problems, but the risk of benefits.
Finally, in this article below, Gottlieb admits to working for Genentech in an interview in 2011.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278114/
By way of disclosure, I’ve done work with Genentech
This is interesting. Was Gottlieb paid for his defense of Avastin? Is this the “work” that he is speaking of? Was Gottlieb a consultant paid by Evan Morris or one of his PR Firms to help delay the FDA decision on Avastin? When Gottlieb wrote the article in the Wall Street Journal, was he on Genentech’s payroll? Was the American Enterprise Institute paid by Morris?
Please see Gottlieb’s recent letter regarding his current conflicts of interest:
It is interesting that Gottlieb doesn’t mention his “work with Genentech” in this letter. Perhaps he did all he could for them already..Or Did he lose his Genentech contract when Evan Morris died?
Evan Morris, Scott Gottlieb, Congress and Biosimilars/Follow on Biologics
One last Strange Link between Evan Morris and Scott Gottlieb is the lobbying effort to prolong the profit stream for Expensive Biologic drugs. Generic forms of these drugs are known as Follow-On Biologics or Biosimilars.
In 2009, Genentech’s lobbyists may have of gotten “caught red handed” by the NY Times feeding talking points to an alarmingly high number of Congressman regarding this topic. Please see the article below:
Statements by more than a dozen lawmakers were ghostwritten, in whole or in part, by Washington lobbyists working for Genentech, one of the world’s largest biotechnology companies.
E-mail messages obtained by The New York Times show that the lobbyists drafted one statement for Democrats and another for Republicans.
Evan Morris was also quoted in this 2009 NY Times Article:
In recent years, Genentech’s political action committee and lobbyists for Roche and Genentech have made campaign contributions to many House members, including some who filed statements in the Congressional Record. And company employees have been among the hosts at fund-raisers for some of those lawmakers. But Evan L. Morris, head of Genentech’s Washington office, said, “There was no connection between the contributions and the statements.”
Sure enough, Gottlieb had a alot to say about follow-on biologics/biosimilars as well. In fact, Gottlieb’s Pharma friendly messaging regarding the biosimilar debate is frighteningly consistent with Big Pharma/Big Biotech.
Guess who supports Scott Gottlieb as the new FDA Head….
“The Biosimilars Forum congratulates Dr. Scott Gottlieb on his nomination as the next Commissioner of the FDA. If confirmed, we look forward to working with him to advance policies that will bring safe and effective new biosimilars to patients promptly so that that these potentially life-saving drugs get into the hands of those patients who need them most.”
and who does the Biosimilar Forum represent….Big Pharma!!!
Evan Morris is dead, Scott Gottlieb May Lead the FDA
I wonder if Genentech/Roche’s Evan Morris ever thought that one of the “consultants” hired by Roche for the “business development” of Tamiflu could one day become the FDA Commissioner? Was that his plan all along? May Evan Morris Rest in Peace…
