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Where is Rudy?

That’s what a top executive at Ranbaxy Laboratories wanted to know in September 2008, one month after the former New York City mayor — and now President Trump’s personal lawyer — had been paid a $1 million fee (see this, too) to help the wayward drug maker escape a huge jam.

The generic drug maker faced a clampdown by the Food and Drug Administration over quality concerns and probes by both a congressional committee and the Department of Justice. Giuliani was hired to smooth things over, but a Ranbaxy executive was steamed that Giuliani had sent in a lieutenant from his consulting firm in his stead.

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“Where is Rudy? He has not participated in any meetings at all of substance. We don’t ever get his viewpoint,” Jay Deshmukh complained to his colleagues in an email. Giuliani is “off giving $250K speeches… Get Giuliani involved as much as possible.”

Why mention this episode now? For one, the documents for which I provided links have never surfaced before, but thanks to a source, I can share them with you.

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They also shed some light on how Ranbaxy — which was about to be controlled by Daiichi Sankyo — tried to minimize what became a huge scandal that triggered widespread concern over Indian generic makers and their impact on the quality of the supply chain.

This disclosure, of course, has nothing to do with Trump or his campaign. But the documents offer a glimpse into Giuliani and his previous dalliances with pharmaceuticals, a topic in which he would lead you to believe he has some expertise.

In reality, though, he comes off as a know-it-all — and a harmful one, at that.

A prime example of this medicinal bluster occurred in April, when Giuliani touted the decades-old malaria drug hydroxychloroquine as a therapy for Covid-19. Trump — who wanted to convince the public he was fighting the pandemic — also boosted the drug, despite a lack of evidence.

At the time, Twitter briefly blocked Giuliani’s account for spreading misinformation. And even though studies have subsequently shown the tablet is ineffective for treating Covid-19, Giuliani boasted earlier this month that he was still taking the drug. He also recently told Trump supporters that “people don’t die of this disease anymore.”

Really? Does anyone know where Giuliani obtained his medical degree?

As a consultant, meanwhile, he has the dubious distinction of having advised two of the most notorious prescription drug makers, whose business practices jeopardized the health of countless Americans. As for being effective for these clients, Giuliani had a mixed record.

One client was Purdue Pharma, which sold the OxyContin opioid painkiller. Last week, the company agreed to plead guilty to three felony criminal charges and pay $8.3 billion to resolve allegations of bribing doctors and lying to regulators, among other charges.

But this was not the first time authorities pursued the drug maker.

In 2007, the U.S. attorney in Virginia sought a $1 billion fine and felony criminal charges against the company and top executives for fraudulently marketing its painkiller. The drug maker hired Giuliani to work his government contacts to minimize the damage.

To an extent, the move largely worked. Purdue Frederick, a holding company, wound up paying a $634 million penalty and pleaded guilty to misdemeanor charges. Notably, criminal charges were not filed against the Purdue Pharma subsidiary. This was significant, because the subsidiary would have otherwise been banned from doing business with government health programs, such as Medicare and Medicaid.

Yet this part of the deal was not surprising.

Why? If the subsidiary had been banned, many people in need of pain treatment would have been denied access to a legitimately beneficial drug. The key issue concerning OxyContin, after all, has been that Purdue was accused of downplaying the risks of addiction for years, while unduly influencing some doctors to overprescribe or inappropriately prescribe the drug.

Nonetheless, Giuliani won credit for the maneuver. And as a result of the deal, Purdue was allowed to keep doing business as usual — which, as subsequent probes have shown, included egregious marketing practices that contributed to the opioid crisis and caused unnecessary turmoil.

Yes, this is what he was paid to do and it’s unfair to say Giuliani could have known what Purdue would or wouldn’t do next. But would you want that on your head?

As for Ranbaxy, Giuliani was less successful.

In October 2008, Giuliani and his team set certain goals for helping Ranbaxy, which by then was fully controlled by Daiichi Sankyo and was trying to get out from under the thumb of the FDA. But a lot of work had to be done.

A Giuliani Partners memo from that time lists such “goals and deliverables” as ensuring three manufacturing plants become compliant with FDA regulations, convincing the FDA to lift import bans on numerous drugs and approve new medicines, and eliminating the perception that quality-control problems were systemic.

Ultimately, the Giuliani team sought to ensure that “Ranbaxy will proactively and positively reinforce its corporate image and reestablish confidence it its products with customers, employees, shareholders and regulatory agencies worldwide,” according to the memo. This was emphasized in a planned November 2008 visit Giuliani made to Ranbaxy in India.

You don’t need to be a regulatory expert, however, to know such steps were necessary.

In any event, things didn’t go as planned. Giuliani was unable to convince the U.S. government that Ranbaxy operations were trustworthy. An FDA import ban on two key facilities, for instance, lasted several years.

In 2013, Ranbaxy paid $500 million to U.S. authorities for falsifying testing data and manufacturing drugs that failed to meet safety standards, the largest such settlement of its kind. At the same time, Daiichi was looking for a buyer for the company after taking huge charges.

So where was Rudy?

By then, Giuliani was long since gone. How much the Giuliani firm was paid in total for its work is unclear.

At the end of the day, though, Giuliani is like any consultant who wants to get paid for giving advice or fixing a problem. But he is no public health expert and, whether he is working for Trump, Purdue or Ranbaxy, his first interest is his client — not the public good.

  • I can’t say this is shocking, but it is a solid, well-written presentation of newfound facts. Nice work as usual, Ed.

  • Ed:

    There is saying in India that crooks hangout together and the first opportunity they get, they will back stab who is not on top of their game. Client is the first one to be the victim as they have access.

    So be on look out. Be safe and well.

  • I’d say “I’m shocked–SHOCKED…” but.
    It’s harder and harder to be surprised by any of this. Important story, and thanks for bringing it. I expect it to sink in that “swamp” that was drained (though in fairness, this started during the GWB era).

  • There’s more where that came from. In 2004, PhRMA commissioned Guiliani Partners to conduct a study linking drug imports from Canada with an increased terror threat. PhRMA annouced the report in a press release “Giuliani Report Calls for Immediate Moratorium On Drug Importation Legislation. PhRMA took it down but Wayback Machine still has it: https://web.archive.org/web/20051102235750/http://www.phrma.org/mediaroom/press/releases/11.04.2005.1163.cfm.

    That same year, PhRMA commissioned the writing of a fiction novel in which terrorists poison Canadian drugs to kill Americans how need more affordable medicine. https://slate.com/technology/2005/11/the-drug-industry-s-literary-misadventure.html.

    Can’t make this stuff up…

  • Public health = public good = public justice!
    Profiting from (millions of) people’s lives and their health needs a distinct description, other than ” just murderer”!

    • Hi Daniel Leach,

      Thanks for the note, although I can’t be sure if you’re being serious or sarcastic.

      But for the record, any alleged murderer is entitled to a legal defense, because that approach is for the benefit of the public good.

      Perhaps I need another cup of stimulation, but feel free to clarify what you meant in case I misunderstood and failed to answer your question.

      Regards
      ed at pharmalot

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