Did Hillary, Obama, and the DNC Choose Fundraising Over Lung Cancer Patients?

Lung Cancer Patients Need a Champion

As a Pharma Whistleblower, and one of the first in the Cancer Setting, I’m continually monitoring the changes in the field of cancer, and Pharma Marketing. I read medical journals, scientific blogs, legal blogs and financial news every day to keep up with developments in this area. When I found this blog below from Karin, a Blogger and Lung Cancer Patient, I felt that my job as a whistleblower hadn’t finished. Please link to her blog, and focus on the quote below:

They LIED!!!!! I NEVER had acne this bad!!!! OH MY GOD!!! I was miserable… in pain… acne on my chest… in my ears… in my hair… on my butt… yes, you read that right…. and my face… OOOOOOOOOh….. it was NOT fun! I ended up taking myself off of the pill… for two weeks… I did go in and see the oncologist… who want me to remain on the pill… but did put me on a lower dose instead… I ended up losing a day and I was concerned as to whether or not I’d be able to pull off Thanksgiving…. Which I did…. it actually turned out beautifully….

Karin experienced this suffering while Genentech, the maker of a 150mg pill for Lung Cancer, was under investigation for fraudulent marketing practices by the DOJ for the pill she took. Despite this investigation, and the suffering of patients like Karin, the company enjoyed top tier access to President Obama and Hillary Clinton through DNC and other fundraisers designed for the corporate elite. My blogpost provides an overlay of their top tier access, and the minimal outcome of the DOJ settlement on their corporate activities and their bottom line. I haven’t been brave enough to try to contact Karin. but I fear that based on her stage of therapy, she may not have lived much longer after she wrote her blog.

As a country we should not take the suffering of cancer patients for granted. Today we are asking many cancer patients to not only spend thousands of dollars on expensive therapies, but also to deal with horrible side effects…for drugs that may not be the best therapy for them. Companies are making thousands of dollars off individual patients whom may derive no benefit from the drug, and experience horrible side effects. I fear that our politicians are protecting these profiteering practices of the Big Pharma companies…Allowing them to Profiteer from Cancer patients without optimizing the science behind their therapies.

A Whistleblower from the “Deplorable Class”

Photo of Brian Shields in 1990 with grandfather Stanley (now deceased) in West Point, NY
Photos from the early 70’s of Brian’s Parents, Gerald Shields and Elaine Shields (now deceased)

44 years ago, I was born on Staten Island, NY to a hardworking young Baby Boomer couple. My father was a Vietnam Combat Veteran, and Meter Reader for Brooklyn Union Gas, and my mother was an 8th grade Catholic School Teacher in the Stapleton neighborhood of Staten Island, the neighborhood made famous by Ghostface Killa from the Wu Tang Clan.

My mom didn’t make any political connections in Stapleton. Like many teachers, she just helped a lot of 8th graders learn to become successful for themselves and their families. She helped a lot of kids beat the odds!

Watch this video for a real life look at Stapleton:

When I was accepted into West Point in the early 90’s, I didn’t understand it when people would ask me and my father, “Who did you Know?” My father would say that we didn’t know anybody, “Brian just got into West Point on his own!” and most people in NY and especially Staten Island wouldn’t believe it.

Taking on the Global Elite

Well, we really didn’t “know anybody” political. I really didn’t learn what that phrase meant until I became involved in a Whistleblower Case against Genentech, (Parent: Swiss company Roche.) The Roche company and family are among the most powerful and wealthy in the world. I doubt that they have ever been to Stapleton.

*All Bolded Comments are my own edits to the quotes from the articles below

Also, the leadership team members from Genentech during the covered period of my settlement have mostly moved on to become some of the top leaders in the world. Genentech’s former CEO, Art Levinson is currently the Chairman of the Board of Apple.

Levinson was one of the first people Jobs told about his cancer and his decision to try alternative therapies. Levinson “pleaded every day” with him, according to Isaacson. The fights almost ruined their friendship. “You cannot solve this without surgery and blasting it with toxic chemicals,” he told Jobs. “That’s not how cancer works.”
Dr. Desmond-Hellmann’s years in pharmaceuticals left her, by her own account, “very, very wealthy,” with a fortune that she and her husband expect to give away.

Genentech Settled for a Small Fee and Profited in the $Billions

Genentech Settled allegations related to illegal marketing of Lung Cancer Drug Tarceva with the Justice Department on June 6, 2016. Genentech and their partner Astellas agreed to share the payment to the government, $67M as part of the settlement, and did not agree to admit to any wrongdoing. I was awarded a relator’s share of 17% of the settlement (Minus my attorney’s share, Federal and California state Income taxes). Genentech and Astellas, huge multinationals, shared the cost of a $67M settlement. Tarceva generated about $4 Billion in sales during the period of the alleged fraud. The settlement represented about only 2% of their U.S. sales during this period. The state of California will collect more from my taxes of the whistleblower settlement than they will collect from Genentech’s settlement of alleged fraudulent practices of their Medicaid Patients.

Whistleblowers don’t know anyone. For the companies, it is a different story…and I made some amazing observations along the way.

The Specifications of the Settlement Were Scientifically Inaccurate

Low Amount, weird specifications, no admission of wrong doing, and no Corporate Integrity Agreement: Despite involving the alleged fraudulent marketing of Tarceva for Lung Cancer Patients, a fraud which could have caused an earlier and more painful death in these poor suffering patients , with a product with well over $4B in sales during the covered period, the settlement amount was one of the smallest in Whistleblower History for a Big Pharma Product. In fact, regional hospital systems and even Herbalife have paid multiples larger than Genentech’s settlement. Also, Genentech at this point was settling their 3rd pharma fraud case and was still not receiving a Corporate Integrity Agreement, nor admitting to wrongdoing. But Why? The reason may be in the odd details of the settlement as reported by the Justice Department. The settlement states the following from the Justice Department Press Release:

The settlement resolves allegations that, between January 2006 and December 2011, Genentech and OSI Pharmaceuticals made misleading representations to physicians and other health care providers about the effectiveness of Tarceva to treat certain patients with non-small cell lung cancer, when there was little evidence to show that Tarceva was effective to treat those patients unless they also had never smoked or had a mutation in their epidermal growth factor receptor, which is a protein involved in the growth and spread of cancer cells.

The term, “unless they had never smoked” is odd. The drug doesn’t work in patients based on smoking status. In 1st Line NSCLC, Tarceva only works on patients with EGFR mutations. If a Never Smoker has EML4/ALK or ROS1 based on a test of their tumor, they should receive drugs indicated for those specific forms of Lung Cancer Disease. Why did the government include never smokers in this settlement language when it is an erroneous Medical term? Obviously, it was helpful for Genentech because they marketed the drug allegedly for thousands of never smokers in the 1st line setting for Non Small Cell Lung Cancer. Allegedly, they discouraged the testing of EGFRmut status in Never Smokers by Oncologists. This “never smoker” language significantly reduced the covered conduct of the settlement and settlement amount by potentially $Billions. If we refer to the scientific data from the period, there was no prospective data from a trial that demonstrated the benefit to Never Smokers for Tarceva. All of the data supporting this Never Smoker argument were retrospective subset data — and eventually the data were proven to be signals from the EGFRmut.

So why did the Justice department include scientifically invalid data in their settlement language? Weird!!!

Genentech Caught a Break with the Settlement Date and Time

June 6, 2016, in the late afternoon Pacific Time was the timing of the Justice Department Press Release regarding the Tarceva settlement. This was really the final day of ASCO, and most of the BioTech Press and more importantly for Genentech, their customers the Oncologists, would be on planes traveling home. In fact, if a Biotech company could ask for a specific data and time to release bad data, it would probably be at this time when most of the attendees of the world’s biggest cancer conference would be traveling home. The timing of the announcement seemed to have been perfectly timed to suit Genentech and minimize press coverage of their settlement.

After the Settlement, Genentech Sent an Unusual Letter to Doctors

Shortly after the settlement, something totally unexpected happened. On June 27th, 2016, Genentech and OSI/Astellas released a “Dear Healthcare Professional Letter”. This letter was entitled, “Important Correction of Drug Information.” There was no press release. There was no Tweet. This letter was posted on Genentech’s website, and I guess it was emailed to doctors in their database. Basically, the letter to Healthcare Professionals validated part of my allegation that Tarceva was not effective in patients with Wild Type EGFR based on a study known as IUNO. So why is this important? From 2005–2013, Genentech made billions marketing Tarceva for these Wild Type EGFR patients with Lung Cancer. In fact, the company allegedly discouraged doctors from testing for the EGFRmut. As late as October, 2009, the testing rate for EGFRmut was less than 10% of Lung Cancer patients, according to OSI’s Gabe Leung in a conference call. Why did the government ignore this information in their settlement with Genentech? Did the FDA fail to keep the Justice Department in the Loop? Why didn’t they hold the company accountable for their initial submission of the Lung Cancer registration trial, BR.21., particularly the weird retrospective biomarker data (that Memorial Sloan-Kettering Researchers publicly ridiculed in the New England Journal of Medicine Letters to the Editor?)This was the data that OSI had used to claim, “EGFR Mutation is not the Story” in an investor slide deck.

Why was the settlement so small, when thousands of patients over nearly a decade in the U.S. (and around the globe)were treated with a drug that was found to be less effective than placebo for EGFR wild type Lung Cancer in the IUNO trial? And why was there no press at all talking about this IUNO trial that would rescind two previous registration trials (BR.21 and SATURN) and their associated FDA labels? Regulatory agencies from around the world commented about the IUNO trial for the 9 months preceding this surprising letter from Genentech to U.S. Oncologists. However, we still have not heard a word from the FDA. New Zealand seemed to have been first to act in December 2015.

Genentech Had Incredible Access to Our Nation’s Leaders During the Investigation

Tarceva Marketing Team Medical Director Pays for Access to Obama During Investigation

DNC Leaks was released in July 2016. Within the DNC Leaks data is a spreadsheet listing the campaign fundraisers for the DNC over the last several years. On November 25, 2013, President Obama visited the Bay area to attend several fundraisers. He spoke at the SF Jazz Center, and later attended a “Discussion”(as labeled by the DNC spreadsheet) at Salesforce.com CEO’s Mark Benioff’s House. The “Discussion” was listed as costing $34K per attendee, and was attended by some of Silicon Valleys’ Best and Brightest (and Richest). The earlier event at the SF Jazz Center actually received some press that was critical of the DNC’s fundraising. Apparently, the ticket cost to attend the event was lowered to $500 from the original $1000. The DNC claimed in quotes to the press that more space was made available and the ticket price drop was not an indication of lack of interest or demand. In viewing the DNC spreadsheet, there were two interesting donations made across two days just prior to the SF Jazz Center event of $21,000 and $9,000, (totaling $30,000) by Paula O’Connor. This was by far the largest donation amount for the event, and may have qualified Dr. O’Connor to be the Chair of the event (based on the DNC invitation data). Dr. O’Connor worked for Onyx pharmaceuticals at the time of this event, and this was the largest political donation ever made by that company’s employees based on opensecrets.org. Dr. O’Connor’s largest political donation was $1250 prior to this event, and she has not made a publicly reported political donation since this event. Below is a Bay Area article about Dr. O’Connor:

Dr. O’Connor was the Medical Director of the Tarceva Marketing Team which marketed the drug regardless of EGFR status in NSCLC during her tenure with Genentech, including the alleged marketing to specific patients mentioned in the Justice Department settlement. Based on Genentech’s organizational structure, she was probably the only Medical Doctor/Trained Oncologist on the Tarceva Marketing Team during a critical period for the drug. She was also the medical doctor that trained my class during our initial Tarceva sales school training at Genentech’s Headquarters in South San Francisco in 2008.

The Government mentioned the following in their press release:

The settlement is the result of a coordinated effort by the Civil Division’s Commercial Litigation Branch and the U.S. Attorney’s Office for the Northern District of California, with assistance from the HHS-OIG, the HHS Office of Counsel to the Inspector General, the HHS Office of the General Counsel-CMS Division, the FDA’s Office Chief Counsel, the FDA’s Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management, the FBI, the Department of Defense Office of the Inspector General, the Office of the General Counsel for the Defense Health Agency and the National Association of Medicaid Fraud Control Units.

Based on the government agencies involved (especially the FBI and FDA office of criminal investigations), I believe that all readers can assume that there was an investigation. Also, based on this timing in 2013, these agencies were probably well into their investigations of Genentech’s Marketing practices of Tarceva.

Why did President Obama meet with the physician associated with Tarceva’s Marketing team in the midst of a Justice Department Criminal and Civil Investigation of alleged fraudulent marketing practices of a cancer medicine?

Dr. O’Connor was the only donor listed on the DNC spreadsheet to pay $30K for the “Lunch” on November 25, 2013, and she was possibly the Chair of the event based on the DNC’s data.

Did President Obama know that she was the Medical Director of the Tarceva Team during part of the alleged fraudulent acts?

Did he know that the Justice Department was investigating Tarceva and Genentech?

The Justice Department’s office is about a mile from the SF Jazz Center. Couldn’t an agent have sent a note to him or his team members? Or the DNC organizers?

If Dr. O’Connor was ever investigated by government agents, did her association with the President during the investigation influence her interview?

Did she speak with the President about Tarceva and Genentech during this DNC fundraiser?

…So many questions from an outlier donation. Does she know that all Geneentech employees may still be personally accountable for their actions based on the terms of Genentech’s settlement?

6. Genentech’s CEO During the Alleged Fraudulent Marketing of Tarceva Has Close Ties to President Obama

Art Levinson was the CEO of Genentech and sat on the boards of Google and Apple at the time. He would later be the Chairman of the Board of Apple, Chairman of Genentech, Board Member of Roche, and eventually become the CEO of Google’s Healthcare Division known as Calico. Despite all of these grandiose appointments, the fact remains that he was the CEO of Genentech during the alleged fraudulent marketing of Tarceva.

7. Genentech’s Powerful CEO Attends Dinners with Obama and Silicon Valley Elite

On February 8, 2011, Art Levinson, along with Mark Zuckerberg, Steve Jobs, and various other Silicon Valley illuminaries met with President Obama during a celebrated dinner. This makes sense. Levinson was a top Silicon Valley leader, and was a peer Board member with Steve Jobs, and the guys from Google as well. The Dinner was at John Doerr’s House and was known as the “Billionaires Dinner”.

Levinson is the guy to the left of Zuckerberg with the ugly tie in this photo on the left. Zuckerberg just placed him on his board for his $3 Billion Medical Foundation.

8. Levinson is a Big Donor to Obama’s Victory Fund and the DNC

In September, 2011, Levinson donated $10,000 to Obama’s Victory Fund, $10,000 to Obama and about $5250 to the Democratic National Committee.

8. Genentech Pays Big for Obama Inauguration Party

In January, 2013, Genentech was the 6th largest sponsor for President Obama’s Inauguration. Genentech donated $750,000 to the inauguration.

In the Huffington Post report below, the reporters note that there were no caps on the fundraising for this event, allowing corporations like Genentech to give extraordinary amounts.

Quote from the Article Below:

Another company with health care interests, Genentech, a subsidiary of the Swiss drug firm, Roche, also donated.
“Genentech works proactively to ensure that the company plays a positive role in the communities in which we live and operate,” the company said in a statement. “Genentech is proud to provide support for the presidential inauguration.”

9. Obama Gives Former Genentech CEO a National Medal While His Former Company Was Under Criminal and Civil Investigation for Marketing Practices

On October 3, 2014, President Obama named Art Levinson a recipient of the National Medal of Technology and Innovation. He awarded Levinson this award on November 20, 2014.

Below are the remarks made by President Obama regarding Art Levinson’s Award at the White House:

Arthur Levinson. National Medal of Technology and Innovation to Arthur Levinson, Calico, for pioneering contributions to the fields of biotechnology and personalized medicine, leading to the discovery and development of novel therapeutics for the treatment of cancer and other life-threatening diseases.

Sadly, it does not seem like Karin enjoyed the benefits of personalized medicine mentioned by Obama above. Based on her blog, she seems to have received Tarceva as salvage therapy after chemo, and experienced horrible side effects which caused her to stop therapy.

This is Levinson’s real legacy as a scientist →the failure to optimize Tarceva’s research and clinical use for Lung Cancer patients. He should not get an award from the President for this failure!

Wasn’t this award from Obama possibly overlapping with the timing of an active criminal and civil investigation into the marketing practices of an organization Levinson managed? Levinson made public comments about Tarceva and was actively involved in their BioTech portfolio. Maybe President Obama didn’t get the memo from the Justice Department, HHS, FDA, FBI, CMS, etc. that Genentech was under investigation. Did any investigators from the government ever discuss Tarceva with Art Levinson? Tarceva was a big part of Genentech’s stock market rise in the early 2000’s; and even the cause of a $14 Billion Collective Market Cap Bump in One Day in 2004 across $DNA and $OSIP!

Profitable biotech companies like Amgen and Genentech have been trading for about 5.6 times 2006 sales. So Zhang figures that Tarceva’s lung-cancer sales should be worth about $3.5 billion to the stock-market values of its selling partners OSI, Genentech and Roche. But those firms jumped a collective $14 billion last Monday. And he has got no idea why stocks like Abgenix and ImmunoGen jumped in sympathy.
“That’s scary,” Zhang says of the spike.

Below is a Press Release Statement from 2004, regarding Tarceva’s FDA approval for Lung Cancer based on the BR.21 Trial — This is the same trial data in EGFR untested patients that may now be obsolete based on the IUNO results. — The BR.21Trial and FDA Indication helped earn nearly $4B in U.S. sales for a drug that eventually didn’t show a benefit over sugar pill in EGFR wild type patients in IUNO.

“The FDA approval of Tarceva™ is the result of extraordinary effort and commitment by many employees at OSI and Genentech, clinical investigators, the FDA, and most importantly, the patients who volunteered to be part of the clinical trial that resulted in this approval,” said Arthur D. Levinson, Ph.D., Genentech’s chairman and chief executive officer.

Most of the patients that Levinson thanked above probably died with little to no benefit from the drug. Despite public knowledge about the important discovery of EGFRmut, the BR.21 trial was never amended by Levinson or his corporate leaders.

9. President Obama Appoints Genentech Insider to Lead the FDA While Genentech Was Under Investigation

The appointment of Robert Califf as the new head of the FDA is another knod to Roche and Genentech’s power . Dr. Califf and the Duke organization where he worked were clear partners with Genentech at a critical time for the company in the early 90’s. Califf was instrumental in getting Genentech’s stock on the right track vis a vis the GUSTO Trial. Califf organized Genentech’s GUSTO trial which led to the eventual FDA approval of Genentech’s first blockbuster product. As a result of this trial, and Roche’s increased investment in the company, Genentech recovered from prior failures in the 90’s and was on the path to the Stock Market Darling it eventually became.

Once again, this appointment of an industry insider with close ties to Genentech, at a time when the company was being investigated for fraud sends a clear signal to investigators. Clearly the White House didn’t care much for my Tarceva Whistleblower case, otherwise, they would not have chosen an FDA leader with such close ties to Genentech, and exceptionally close ties to Genentech’s legacy during the active investigation.

10. October, 2012 — FDA Sends Letter to Low Level Genentech Associate Director to Address Patient Risks of Tarceva Marketing

One of the allegations of my whistleblower compliant was the use of retrospective rash data to inflate the dosage and sales of Tarceva. Allegedly, this was a tactic whereby the sales team would encourage doctors to dose Tarceva until the patients received a horrible rash, because some retrospective data indicated that people with a rash tended to have better success with Tarceva. The FDA addressed this behavior in a 2012 letter to a low level regulatory person at Genentech. The FDA sent this letter to Genentech about 1 year after my complaint was filed with the Justice Department. Also, despite this letter and the FDA’s admonishment, Levinson received his National Prize. However, this behavior was never mentioned in the settlement with Genentech in 2016. Below is a quote from the FDA NOV (Notice of Violation) Letter to Genentech:

Finally, this presentation minimizes the risks of Tarceva by portraying the adverse reaction of “rash” as an efficacy predictor and therefore a potential benefit to patients. According to the Tarceva PI, grade 3/4 rash was reported in 5% of patients in the Tarceva + gemcitabine arm and resulted in dose reductions in 2% of patients and study discontinuation in up to 1% of patients. We note that the page includes the statement: “These data do not support increasing the dosage of Tarceva to cause patients to develop rash,” however, this statement does not mitigate the misleading impression conveyed by the presentation above.

Below is more information and disturbing images of the Tarceva related Rash in patients from cancergrace.org

The article below refers to this rash as “acneform eruption”

Below is a another link to a Karin’s blog in 2014. She includes a photo of the Rash brought on by her Therapy. The FDA Letter is in response to Marketing Practices which encouraged doctors to dose Tarceva until they induced a rash like Karin’s in their patients.

So a low level Regulatory Manager at Genentech received a received a letter from the FDA because their sales reps were encouraging doctors to “dose to rash” for increased profits and pain for patients…and the CEO,Art Levinson received an award from Obama!!! Am I missing something???

10. Genentech’s Law Firm During the Investigation Was a Major Contributor to Obama and the DNC

The Obama Victory Fund had another Interesting Donor, Genentech’s Law Firm Sidley Austin is listed as one of the top 10 donors to Obama’s Victory Fund. What’s also interesting is that Sidley Austin is the same Law Firm that employed both President Obama and the first lady, Michelle Obama,where they first met.

What’s interesting is that Sidely Austin, a private Law Firm is ranked in the top 10 in the chart below for contributions to Obama’s Victory Fund. This Law Firm is ranked in the same class as Tech Giants Microsoft and Google, and ranked just behind the banking behemoth, Goldman Sachs!

Was Sidley Austin’s contribution to Obama a pass through from their client to Obama? Was the DOJ used as a shakedown mechanism by the DNC’s fundraising committees? It is interesting to see that Goldman Sachs is listed just above Sidley Austin — -another firm with DOJ investigations at the time!

Top 10 Contributers to the 2012 Obama Victory Fund via opensecrets.org

11. Sidley Austin Partner is a Major Fundraiser for Obama. Meets with Him Just Prior to Genentech’s Settlement with the Justice Department

Sidley Austin partner, Robert Peitrzack, gave $32,400 to the Inauguration of President Obama in January 2013. According to opensecrets.org, he maxes out regularly to the DNC and Obama’s fundraising efforts. According to Emails in Wikileaks, he met with President Obama just prior to the settlement with Genentech in a Roundtable on May 18, 2016. In fact, he was extremely persistent with the DNC staffers as he attempted to set up this event according to Wikileaks emails trails.

I’m sure Sidley Austin manages many big clients and this Lung Cancer case was but a drop in the bucket to them. However, they do like to brag about their Genentech successes…From their Website:

Represented Genentech in connection with a lengthy criminal and civil investigation regarding Rituxan

In another article about Sidley Austin’s uber Attorney/Oncologist, Paul Kalb (so-called “Health Care MVP”, they brag even more about this Rituxan Case.

Achievements over the past year including settlement of an investigation into Genentech Inc.’s allegedly illegal promotion of rheumatoid arthritis drug Rituxan for $20 million without imposition of a corporate integrity agreement.

Yes that’s right, once again, Genentech avoided a corporate integrity agreement with Sidley Austin’s Paul Kalb’s help.

12. Genentech’s Law Firm Once Employed President Obama and First Lady Michelle Obama

In the Summer of 1989, Michelle Obama (Robinson) was a first year associate at Sidley Austin and was chosen to mentor a new Harvard Law School Graduate, Barrack Obama.

12. In 2012, Obama’s Labor Secretary is Under Investigation, Sidley Austin to the Rescue

In 2012, Sidley Austin represented Obama’s Labor Secretary Hilda Solis in Federal Fundraising Inquiry. This inquiry was related to DNC fundraising activities in the LA area which involved President Obama. Apparently, Solis owed Sidley Austin between $50–100K for legal support and this was disclosed in FEC documents.

12. A Prosecutor from the Justice Department’s San Francisco Office Defected to Sidley Austin to Defend Genentech during an active case

Joshua Hill, joined Sidley Austin immediately after working for the Justice Department in the Northern District of California. He represented Genentech on the Tarceva case. Sidley Austin proudly mentions that Joshua Hill joined their firm on June 18, 2012. This was about 9 months after my Whistleblower case was filed under seal with the Northern District of California. How helpful was this seal if Genentech’s Law Firm could hire away one of the Federal Prosecutors for their case? Doesn’t the Justice Department have a non-compete clause? Maybe he wasn’t on the case — -Maybe it was just a coincidence.

Also did Hill save Genentech from criminal prosecution? He seems to be bragging about saving some Big Pharma Co. on the Sidley Austin website:

Representing a leading pharmaceutical manufacturer in parallel U.S. Department of Justice criminal and civil investigations related to allegations of false and misleading promotional practices. The government declined criminal prosecution.

13. Law Clerk and Obama Campaign Director Leaves Justice Department in Northern CA to join Sidley Austin and Possibly the Genentech Case

Jennifer Gaspar, another member of the Sidley Austin Team also joined the Law Firm in 2012 after working as a Law Clerk for the Northern District of California. The same office that Hill worked for. On Sidley Austin’s website, below is her current experience:

Representing pharmaceutical manufacturer in a criminal and civil investigation brought by the Department of Justice.

Gaspar was also the Voter Protection Director for the Obama 2012 General Election Campaign Organization, North Carolina.

So did Sidley Austin recruit two Prosecutors from the Northern District of California Justice office in San Francisco specifically to support Genentech on this whistleblower case? Or, was the timing just right? These two members of the Northern California District Justice Department just happened to leave their government paying jobs, for the riches of Sidley Austin, and may have walked right into representing one of the biggest corporations in the nation, a $240 billion Behemoth — -and also representing the former company of the Chairman of Apple Computer. Maybe they just got lucky and they walked right into a great situation?

So who was making all these moves to bring DOJ attorneys over to support Sidley Austin during an active DOJ investigation for the Northern California District office? Who had insider connections into the local DOJ office for Sidley Austin? Perhaps it was former Assistant District Attorney, and current Sidley Austin Partner David Andersen?…and lead attorney representing Genentech on the Whistleblower case.

From the Sidley Austin website above:

Later in his career, he served as an Assistant United States Attorney (AUSA) and First Assistant United States Attorney (FAUSA). As FAUSA, he had responsibility for all criminal, civil and tax cases brought by or against the United States in the Northern District of California.
Dave has represented AT&T, Dynegy, Facebook, Flextronics, Genentech, STMicroelectronics, Wells Fargo and numerous individual clients

14. Sidley Austin Attorney and Former Obama for America Committee Member Joins Genentech as Corporate Council

According to her Linkedin account, Erica Michele Jackson, Corporate Council at Genentech left her role at Sidley Austin in San Francisco to join Genentech in 2015. She was also a member of Obama’s Committee for Healthcare in 2008. Lots of revolving doors on this case — Genentech, Sidley Austin, Justice Department, and Obama’s committees. They must have a tight Linkedin Network.

15. Genentech sponsors Hillary Clinton Speech at BIO conference

In January 2014, Hillary Clinton gave a 50 minute speech at the BIO conference. According to the conference, this speech was sponsored by Genentech. I’m not sure what Genentech paid for the speech, but TIME reported that BIO paid a “Clinton Speaking Fee” of $335,000 in 2014. This was Hillary Clinton’s highest reported payment for a speech. The NY Times also reported $10M paid by BIO in 2014 Lobbying Fees.

Hillary Clinton speeks at BIO Conference 2014, session sponsored by Genentech

NBC 7 San Diego reported on the event which included discussions of GMO support, the Iran Deal, Iraq, China, and Putin. One of the more interesting quotes from Hillary Clinton hints at a sort of Corporate Welfare Program for BioTechs. From the 14–19min mark of this video, Clinton discusses her support of a Corporate Welfare program for BioTechs, almost insuring profit, with the support of government scientific and regulatory agencies. She mentions this as a possible necessity to combat subsidies by other nations for their Biotech research companies. Of course, providing tax advantages to Biotechs are mentioned as well, to the overwhelming applause of the Big Pharma crowd.

“Is there any way in our system to embed some kind of foundational insurance against risk that could be available to all of you that do this importnant work.”

Another aspect of Clinton’s discussion is her understanding of the need for companies to make profit with a “Broad Market”and she also mentions targeted therapies — Very interesting since at the time of this talk, Genentech had just received the US indication for Tarceva-a targeted therapy for EGFRmut Lung Cancer. Also, my whistleblower complaint was regarding the company’s profiteering in a broad market when data demonstraterd that the drug was only relevant in a targeted group of patients. Had Genentech prepped Hillary for this talk? Is that the Dilemma that she is having a tough time explaining away in this clip? — ->

It is a dilemma, because if you can’t get quickly enough to a broad enough market, and some drugs by definition are never going to have a broad market because of what you are targeting, but for generalization purposes, if you can’t get to a broad market quickly so that you can get price down and volume up so that you are going to get a return on the investment you made, then you are in a problematic area for your own investors for your fiscal feasibility…”

16. Hillary’s Pick for the FDA, and Major Political Donor, Margaret Hamburg,is involved in RICO Lawsuit. Did She Also Influence the FDA investigation of Tarceva for her Husband’s Hedge Fund?

The above article addresses a recent lawsuit filed by the founder of Judicial Watch, Larry Klayman. Klayman uncovered an interesting association between Hamburg, Hillary Clinton, and her husband’s Mega Hedge Fund Renaissance Capital.

From the Daily Caller article above:

President Obama appointed Hamburg to run the FDA from May 2009 to March 2015, while her husband, Peter F. Brown, was a co-CEO at New York hedge fund giant Renaissance Technologies.
Renaissance had substantial stock in Levaquin-owning Johnson & Johnson during Hamburg’s FDA tenure, according to the lawsuit and U.S. Securities and Exchange Commission records obtained independently by The Daily Caller News Foundation. Forbes estimated Brown earned roughly $90 million in total compensation in 2012.
Read more: http://dailycaller.com/2016/04/21/suit-alleges-former-fda-chief-suppressed-danger-of-deadly-drug-for-sake-of-profit/#ixzz4MKZWv4Zb

The above article also references the significant contributions that Hamburg and her husband had made to Hillary, Obama, and the Clinton Foundation:

This lawsuit is unusual; it shines a light on blatant political corruption — the purchase of powerful executive posts. 
In 2009, President Barak Obama nominated Dr. Margaret Hamburg for Commissioner of the FDA as a political appointee. The suit alleges that Dr. Hamburg and her husband had made large donations to Hillary Clinton’s campaigns, and to the Clinton Foundation. And that they “gave political contributions and gratuities to President Obama to induce him to nominate her to be appointed as FDA Commissioner.”
“Dr. Margaret A. Hamburg was nominated as a result of huge political and other gratuities to Hillary Clinton and The Clinton Foundation, and at Mrs. Clinton’s recommendation.”
The suit further charges that “During the confirmation process before Congress, Dr. Margaret A. Hamburg, acting in concert with her husband, Peter F. Brown, at all material times the Co-CEO of a hedge fund named Renaissance Technologies, L.L.C., failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest –specifically, that Renaissance Technologies, L.L.C. held hundreds of millions of dollars of Johnson & Johnson stock, the manufacturer of the deadly drug, Levaquin.”

Why is this relevant to the Tarceva case?

In October, 2009, Biotech startup Medivation entered into an important partnership with Astellas (the eventual Corporate Parent of Tarceva)to codevelop and copromote the eventual blockbuster drug Xtandi.

Shortly after entering into this agreement with Medivation, Astellas made an offer to purchase OSI for $3.5B which the OSI Board Rejected

Wall Street had a feeling that this deals was bound to happen, despite the Hostile nature of the takeover offer.

from the article above:

After all, Astellas is pretty determined to boost its presence in the U.S. oncology market, and OSI’s Tarceva would be a big step in that direction

And then the FDA sweetened the deal for Astellas and OSI. Despite a 12–1 ODAC vote against approving Tarceva for Lung Cancer maintenance therapy, the FDA approved Tarceva for this new indication.

From the reported article above — see original

Why did the Food and Drug Administration go against the advice of its own advisory panel to approve erlotinib tablets as a maintenance therapy for patients with locally advanced or metastatic non-small cell lung cancer?
Regulatory precedents, trial design, and lack of a comparative effectiveness standard all played a part in the unusual decision, according to Dr. Robert Justice, director of the Center for Drug Evaluation’s Division of Oncology Drug Products.

Robert Justice, the FDA director of “splaining” mentioned above is actually a revolving door bureacrat hailing from Genentech.

So why is this Tarceva decision important? It may have helped get the Astellas deal done with OSI.

So what did Astellas do with this OSI acquisition? Less than 3 years later they shut down this once fabled Long Island, NY operation.

However, all was not lost for Astellas! The partnership with Medivation resulted in the commercialization of a global blockbuster cancer drug, Xtandi.

from the above bloomberg article:

So what does Xtandi have to do with FDA Commissioner Hamburg? Her husband, Peter Brown’s company has been actively trading Medivation since 2010. In fact, his company Renaissance Technologies, invested up to $90 Million in one quarter in Medivation’s stock according to relationalstocks.com

Renaissance Technologies, LLC Medivation Holdings via relationalstocks.com

The above chart includes nearly 5 years of trades adding up to $292M in holdings over a 5 year period. Interestingly, the 2 year gap of no trades in Medivation overlaps with the DOJ and FDA joint investigations into Medivation’s partner Astellas for Fraudulaent Marketing of Tarceva. This investigation could have possibly prevented Astellas from selling any products to Federal Government programs. Did Hamburg tip off her husand to the investigation? Did she influence the investigation in late 2014 when Renaissance started to trade Medivation heavily? Why didn’t she recuse herself from the investigation into Medivation’s Marketing partner while her husband’s hedge fund was actively trading Medivation’s stock.

Did Renaissance Technologies profit from Medivation? Based on the Xtandi driven 5 year performance of the stock, we can venture a guess that this hedge fund of the former FDA Commissioner’s husband did fairly well:

10 year Stock History of Medivation via Yahoo Finance

Summary of Perceived Conflicts of Interest During the DOJ Investigation of Genentech

In summary, I believe that my legal team and the Justice Department employees of the Northern District of California, and the government agents from multiple organizations did an amazing job bringing the case to a settlement with Genentech. They defied the odds against a Goliath that always seems to win. They may have overcome significant Washington D.C. influence to still bring this case to a settlement, and help support the cause for Lung Cancer Patients like Karin. However, more needs to be done to make companies optimize the science behind their therapies for Cancer Patients. Right now, I believe Pharma Companies are doing a too good a job of optimizing their profits…and the system of connected Law Firms, money to politicians, and the revolving door of Federal Agency employees to Corporate Interests is further eroding appropriate oversight of profiteering from Lung Cancer Patients.

An article from today further highlights the disturbing cost/benefit ratio for Lung Cancer Treatments. The Medical Community is speaking-> Are Obama, Hillary, and the DNC Listening?

From the article above:

There are a host of new drugs using new mechanisms for treating non-small cell lung cancer, both tyrosine kinase inhibitors (TKIs) and programmed death 1 (PD-1) agents, that in some cases have won fast approvals and offered new hope. But are they worth their cost?
Not so much, says a new report from the Institute for Clinical and Economic Review (ICER). The report found some very positive clinical results but figures on the cost side, all of the 6 drugs examined — including Merck’s ($MRK) Keytruda, Bristol-Myers Squibb’s ($BMY) Opdivo and Roche’s ($RHHBY) Tarceva — need deep discounts to be worth their cost. For the TKIs, the institute figures drugmakers would need to cut their prices by more than 20% to be worth their cost, and for the PD-1s, discounts ranging to more than 70% would be appropriate.
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