Scott Gottlieb: A Threat to Women’s Health and Safety

Scott Gottlieb Put Politics Before Women’s Health—and He’ll Do It Again

1200x630_Gottlieb_5_ECAs a senior FDA official in 2005, Scott Gottlieb played a key role in defending the George W. Bush administration’s ideologically-driven move to block Plan B (emergency birth control) from being approved for over-the-counter use. Rejecting the advice of FDA’s career scientists and outside experts, Gottlieb and his colleagues overrode the advisory committee’s 24-3 decision, choosing politics over science.

An investigation by Congress’s non-partisan investigative arm, the Government Accountability Office, concluded that the FDA's decision-making process had been “unprecedented.” GAO uncovered that top FDA officials like Gottlieb had told staff they would reject the application before the FDA’s medical experts had made their decision.

During his confirmation hearing, Sen. Patty Murray raised Gottlieb's role in blocking Plan B and asked him, “can you commit to me today that you will not allow [the Trump administration] to use the FDA to further a political agenda against women’s health?” He dodged and ducked, refusing to answer.

Scott Gottlieb Spent His Career Working for Big Pharma Over Consumers. Who Will He Work for as FDA Commissioner?

Scott Gottlieb 7Scott Gottlieb has made millions of dollars consulting for and investing in the pharmaceutical industry and continues to be heavily tied to multiple drug and device makers. From 2013-2015—the only period for which records are publicly available—he received over $400,000 in payments from the pharmaceutical industry. The Wall Street Journal reported that his gross income from just January 2016 - February 2017 was $3 million in speaking, retainer, and consultant fees.

His ties to industry go back to the early 2000s. He has now served or is serving on the board of nine different pharmaceutical companies, with each board appointment paying an average $250,000 to $300,00 per year. He has been a venture partner at New Enterprise Associates since 2007 and the managing director of T.R Winston bank since 2013, both of which have significant investment portfolios in health care. It will be impossible to recuse himself from all meetings that will affect a company’s profits given just how deeply connected to the industry he is.

Back in 2005 when he had far fewer ties, Time Magazine reported that he attempted to intervene when the agency’s experts rejected drugs developed by companies he was close to. What will he push through if he is confirmed to lead the FDA now?

Scott Gottlieb Didn’t Want Women Warned About the Dangers of Menopause Hormone Therapy

1200x630_Gottlieb_1In 2002, the NIH announced that one form of menopause hormone therapy, Prempro, had been to found to cause breast cancer in previously healthy women. Prempro is made by Pfizer, a company from which Scott Gottlieb has received thousands of dollars as a consultant, and possibly more. Despite expert analysis that resoundingly proved the connection between Prempro and breast cancer, Gottlieb claimed the results were, “premature, indefinite, or just plain wrong.” He even argued that the NIH was wrong to inform women of the risk of taking Prempro, claiming that “the data were rushed to print with a carefully orchestrated PR blitz” and that the NIH’s decision was politically motivated.

Gottlieb’s resistance to disclosure in a matter of clear consumer safety is deeply troubling. Rigorous follow-up research has shown that the NIH was right to warn the public: widespread discontinuation of menopause hormone therapy in 2002-2003 was associated with a sharp decline in breast cancer incidence rates in the U.S. That translates to more than 18,000 fewer women diagnosed with the disease each year, adding up to 270,000 since 2002. As a result, thousands of women’s lives were saved.

Scott Gottlieb Wants to Shortcut Critical Testing and Rush Drugs to Market

scott gottlieb 7Even though the FDA is the fastest drug approval agency in the world, Big Pharma friends Donald Trump and Scott Gottlieb have criticized the FDA for being too slow to approve new drugs.2 Under questioning at his confirmation hearing, Gottlieb refused to answer whether he supports requiring all new drug applications to go through critical phase III testing, preferring to “compress the phase II and phase III trials into one." Meanwhile, the FDA released a review this January of 22 case studies where promising phase II results fell apart during phase III testing. In 7 cases, serious safety concerns weren’t uncovered until phase III.

scott gottlieb 8Why take dangerous shortcuts during the stage of testing that reveals how safe a drug will be long-term or how effective it will be at actually treating disease? These trials are expensive for Big Pharma. They are often large studies that involve treating hundreds of people over several years. Time after time, Gottlieb has shown just how far he’s willing to go to ensure that patient safety concerns don’t infringe upon the profits of pharmaceutical companies.

Scott Gottlieb Thinks the FDA is Too Worried About Drug Safety

Scott Gottlieb 4In the 1960s, FDA reviewers concerned about drug safety kept a sleeping pill called thalidomide, already approved in many countries around the world, from being sold in the U.S. Their concerns were justified; women who took thalidomide while pregnant gave birth to children with devastating birth defects. This prompted Congress to give the FDA greater regulatory power, mandating “substantial evidence” of both safety and efficacy before a drug is approved. Gottlieb has accused the FDA of having “an unreasonable hunger” for “extreme certainty about how drugs work.” He has criticized FDA reviewers for "prioritiz[ing] safety over speed” and during his last stint at FDA in 2005, tried to overrule agency scientists who halted a trial for safety concerns.

Even though ensuring consumer safety is a key part of the FDA mission, Scott Gottlieb says the thalidomide episode created a regulatory culture within the FDA that is too concerned with safety. The idea that the FDA is too slow and needs to be streamlined is simply not true. Scott Gottlieb would take us backward to a time before critical consumer protections were in place.

Scott Gottlieb Wants to Speed Up the FDAEven If It Means Clinical Trials Don't Represent Women & People of Color

Scott Gottlieb 3Pharmaceutical companies are supposed to determine if their products work differently in men and women, young and older people, and people from different racial and ethnic backgrounds. We already know what happens when clinical trials lack sufficient diversity. When women are underrepresented, we don’t discover that a drug or device is unsafe or less effective for women until after it is on the market being used by thousands of women. In 2013, for example, the FDA had to cut by half the approved dosage for women taking the sleeping drug Ambien—but only after a startling number of car accidents and sleep-driving incidents were linked to the drug. A 2001 study showed that eight in ten drugs recalled from the market posed a greater health risk to women than to men.

Scott Gottlieb 2In many cases, how a product will affect different people isn’t revealed until phase III clinical trials. Scott Gottlieb has been critical of the FDA requiring for requiring pharmaceutical companies to conduct phase III trials at all, much less ones that focus on safety and effectiveness in specific groups.

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1. Ravdin P, Cronin K, Howlader N et al., “The decrease in breast-cancer incidence in 2003 in the United States,” New England Journal of Medicine 2007; 356 (16): 1670-4.

Cronin K, Ravdin P, Edwards B, “Sustained lower rates of breast cancer in the United States,” Breast Cancer Res Treat 2009; 117 (1): 223-4.

2. Carpenter D, “Scott Gottlieb and the Credibility of U.S. Therapeutics,” New England Journal of Medicine, 2017; 356 (16): 1670-4.