Alberto Espay was not prepared for how his world would be upended when he published a study on the number of people who have died while taking new, high-profile Alzheimer\u2019s drugs.<\/p>\n
Last October, the neurology professor and his colleagues posted the results of their study\u00a0online<\/a>, writing that patients taking Aduhelm and Leqembi were two to nearly three times as likely to die as those treated in the clinical trials. The reaction was immediate and furious: Colleagues accused Espay of using \u201calarmist\u201d language and having a financial stake in maligning the drugs. The University of Cincinnati, where Espay works, told him not to talk to the press without consulting the university\u2019s communications department. Then, law enforcement warned him of a credible death threat against him and his family.<\/p>\n Amid the controversy, the publisher withdrew the article.<\/p>\n There were obvious reasons why some people would want to silence Espay. The new Alzheimer\u2019s drugs are projected to reach\u00a0$17 billion<\/a>\u00a0by 2033, and anything that jeopardized those sales posed a threat to the pharmaceutical companies and their stakeholders. Both academic detractors who\u00a0posted criticisms<\/a>\u00a0of the study online received consulting and research fees from drugmakers.<\/p>\n More shocking was the response from federal regulators tasked with ensuring drugs like Aduhelm and Leqembi are safe.<\/p>\n An official of the US Food and Drug Administration (FDA) cast doubt on Espay\u2019s findings last October, noting in a comment<\/a>\u00a0to the study that the medical data his team had used for its calculations was unreliable. But the information had come from the agency\u2019s own database of medication-related complications and deaths. When asked to provide the correct numbers, the agency refused.<\/p>\n In response to two Freedom of Information Act requests filed this year by the Lever and the international medical journal the BMJ,\u00a0a government official said the number of deaths associated with the drugs doesn\u2019t have to be released. According to an obscure\u00a0FDA regulation,<\/a>\u00a0the FDA could consider such data a trade secret, \u201ceven if such disclosure would be in the public interest.\u201d<\/p>\n \u201cIt\u2019s mind-boggling,\u201d said Espay. \u201cWhen I think of trade secrets, I think of the molecular composition of a drug, not deaths of patients.\u201d<\/p>\n The FDA\u2019s stonewalling came months after President Donald Trump\u2019s Health and Human Services Secretary Robert F. Kennedy, Jr swept into power promising \u201cradical transparency<\/a>\u201d and to \u201cMake America Healthy Again.\u201d Among the new administration\u2019s top pledges was\u00a0cleaning up<\/a>\u00a0the FDA, which over the years has been embroiled in a string of\u00a0controversial drug approvals<\/a>\u00a0and accused of putting the industry\u2019s interests ahead of public health.<\/p>\n According to the president\u2019s domestic agenda blueprint,\u00a0Project 2025\u2019s \u201cMandate for Leadership<\/a>,\u201d all health regulators, including the FDA, \u201cshould be entirely free from private biopharmaceutical funding.\u201d The plan calls for the revolving door to be \u201cshut and locked\u201d so former regulators stop leaving the agency for industry jobs, and pharmaceutical company executives stop \u201cmoving from industry into positions within regulatory agencies.\u201d Martin Makary, the administration\u2019s pick for FDA Commissioner, doubled down on the plan, vowing to end the FDA\u2019s \u201ccozy<\/a>\u201d relationship with Big Pharma.<\/p>\n But far from reducing industry influence, the administration\u00a0installed<\/a>\u00a0a pharmaceutical industry executive in a key FDA position and asked Congress to\u00a0increase<\/a> the money\u00a0companies pay the agency as part of the drug-approval process. That executive\u00a0just resigned<\/a>\u00a0after he allegedly retaliated against a former business associate and voiced concerns about politics influencing the agency\u2019s drug-approval process.<\/p>\n Meanwhile, the Lever\u00a0has uncovered expanded industry ties to some drug-approval advisory committees, as well as several drugs approved this year based on shaky evidence for conditions ranging from cancer to genetic disorders.<\/p>\n It\u2019s the culmination of a decades-long decline in the scientific standards that the country\u2019s preeminent drug regulator uses to determine if medicines are safe and effective.<\/p>\n The FDA has been all too willing to approve questionable treatments on the basis of flimsy scientific evidence.<\/p>\n A\u00a0Lever\u00a0review of all drugs approved by the FDA over a ten-year period found that the majority \u2014 73 percent<\/a>\u00a0\u2014 were allowed on the market without solid evidence that they work. Far from withholding lifesaving drugs, as\u00a0patient advocates<\/a>\u00a0and\u00a0politicians<\/a>\u00a0have charged, the FDA has been all too willing to approve questionable treatments on the basis of flimsy scientific evidence.<\/p>\n Why has the FDA, once an international beacon of\u00a0gold-standard regulation<\/a>, failed so spectacularly? The answer lies with the\u00a0$618 billion<\/a>\u00a0drug industry, which has used its vast resources to influence not only the agency but every stakeholder involved in the drug-approval process, from patients to doctors to universities to medical journals to Congress.<\/p>\n To understand how the industry was able to so thoroughly subvert the FDA\u2019s proclaimed agenda, we interviewed more than one hundred researchers, policy experts, physicians, FDA insiders, patients, and families, plus reviewed thousands of pages of documents. Our reporting suggests the drug industry influences the FDA, both internally and externally, through three main channels:<\/p>\n Along with spending more than\u00a0$3.6 billion<\/a>\u00a0over the last three decades lobbying Congress for industry-friendly legislation, drug companies pay \u201cuser fees\u201d directly to the FDA as part of their new drug applications. This money now accounts for\u00a077 percent<\/a>\u00a0of the\u00a0agency\u2019s drug review budget<\/a>, which could make agency officials\u00a0wary<\/a> of displeasing\u00a0the industry they regulate. The result, according to critics, is an agency that treats industry, rather than the public, as its main client.<\/p>\n \u201cEvery actor in the system that might serve as a check against the pharmaceutical industry selling bad drugs is compromised in some way,\u201d says Jon Hanson, a Harvard University professor of law and medicine. This \u201cdeep capture,\u201d as Hanson calls it, of every institution involved in drug regulations has allowed companies to sell marginally effective if not useless and sometimes harmful products, which can incapacitate patients, bankrupt them, and hollow out their lives.<\/p>\n \u201cThere is not a single aspect of drug regulation where drug companies have not found ways to influence the FDA,\u201d agrees Daniel Aaron, a legal scholar at the University of Utah. \u201cThey are the biggest donors to Congress. They have found ways to change the regulations and laws to diminish premarket review of drugs, co-opted patient groups, and shaped biomedical research in profound ways.\u201d The breakdown in regulation has reached the point, says Aaron, that even a few pharmaceutical executives are concerned.<\/p>\n This is the story of how the FDA was captured by the drug industry, and how, instead of fixing the problem, the Trump administration seems hell-bent on making matters worse.<\/p>\n The cozy relationship between Big Pharma and the FDA began in earnest in 1992 with the passage of the\u00a0Prescription Drug User Fee Act<\/a>. President Ronald Reagan\u2019s White House viewed regulatory agencies not as caretakers of the public interest, but rather as teammates of industry. As then vice president George H.W. Bush put it<\/a>, \u201cGovernment shouldn\u2019t be an adversary [of industry].\u00a0It ought to be a partner.\u201d<\/p>\n At the time, the FDA was hardly a partner of\u00a0industry or patients<\/a>. Companies could submit the results of clinical trials only to wait years to find out if their drugs were approved \u2014 a delay that could cost them millions of dollars in lost revenue, while patients\u2019 health and lives hung in the balance. Along with companies, a few patient advocacy groups, particularly members of the AIDS community, were clamoring for faster approvals. But while public ire was directed at a sluggish FDA, it was the Reagan Administration and Congress that were refusing to appropriate the money the agency needed to hire more staff.<\/p>\n Drugmakers, together with patient activists, began pushing for passage of the Prescription Drug User Fee Act, which would require drug companies to pay\u00a0user fees<\/a> to the FDA to beef up its budget. In return, the agency agreed to put the money toward drug approvals, not post-market safety monitoring, and to complete its reviews of drug applications within twelve months.<\/p>\n David Kessler, then the FDA commissioner and a supporter of the legislation, promised Congress the funding scheme would not threaten the agency\u2019s independence. He\u00a0told<\/a> the\u00a0New York Times\u00a0in 1992, \u201cI am not talking about lowering standards. Or jeopardizing the integrity of product review. I am simply talking about getting the resources we need to keep pace.\u201d By 2001, the\u00a0agency was able<\/a> to hire nearly one thousand additional<\/a> drug reviewers and computerize its systems, slashing review times to fourteen months.<\/p>\n Contrary to Kessler\u2019s assurances, the Prescription Drug User Fee Act has indeed\u00a0led to lower scientific standards<\/a>\u00a0in the name of speedy approvals. Because the bill must be reauthorized every five years, the pharmaceutical industry has had repeated opportunities to lobby Congress and the FDA for ever more concessions, further weakening the agency\u2019s scientific standards and increasing its sense of loyalty to the companies it regulates.<\/p>\n The Prescription Drug User Fee Act has led to lower scientific standards in the name of speedy approvals.<\/p>\n \u201cIt\u2019s hard to overstate the value of [the Prescription Drug User Fee Act] for the drug industry,\u201d says legal scholar Aaron, who spent two years at the FDA after medical school.<\/p>\n One FDA drug safety reviewer said in congressional testimony,<\/a>\u00a0\u201cFDA culture regards industry as the agency\u2019s primary client rather than an entity in need of regulation.\u201d According to a former FDA reviewer, who asked to remain anonymous for fear of retribution, agency managers are afraid to be seen as an impediment to medical progress, and to risk the ire of their pharmaceutical company \u201cpartners.\u201d<\/p>\n That\u2019s one reason pharmaceutical interests lobby hard in the run-up to every reauthorization of the act. In 2024, pharmaceutical manufacturers deployed\u00a0738 lobbyists<\/a>\u00a0\u2014 nearly a lobbyist and a half for every member of Congress. It spent more\u00a0than $151 million<\/a>\u00a0on lobbying, more than any other industry, including oil, banking, and tech, according to OpenSecrets, a nonprofit watchdog group that monitors political contributions and spending.<\/p>\n Thanks to the Prescription Drug User Fee Act, drugmakers also get special access to the FDA. The agency is required to meet with both industry and public stakeholders as it hammers out details of the updated bill, says Reshma Ramachandran, a physician and a codirector of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency. But she says that regulators spend far more time with pharmaceutical representatives than medical experts.<\/p>\n \u201cThey met with us six times,\u201d said Ramachandran of the last reauthorization effort. \u201cThey met with pharma 150 times. If you actually track what pharma says it wants at the beginning of the negotiations over [the Prescription Drug User Fee Act] and what FDA actually commits to, it very much reflects those sorts of priorities that industry has laid out. By the time public stakeholders are able to weigh in, it\u2019s at the end of the process when FDA has already negotiated everything with industry.\u201d<\/p>\n The FDA did not respond to multiple requests for comment on the matter.<\/p>\n The passage of the Prescription Drug User Fee Act did more than open a door to regulatory capture. It also alerted industry to the power of a potential new ally \u2014 one that few would expect.<\/p>\n In 2016, Kim Witczak was sitting in an FDA meeting room in Silver Spring, Maryland, listening to testimony from the families of patients with Parkinson\u2019s disease. A marketing executive and drug safety activist from Minneapolis, Witczak was a consumer representative on the FDA\u2019s drug advisory committee reviewing Nuplazid, a new medication to treat a devastating condition known as Parkinson\u2019s psychosis.<\/p>\n During the public portion of the meeting, patients and family members stepped up to a microphone one by one to tell their stories of the hallucinations, delusions, and personality changes \u2014 and to plead for the drug\u2019s approval.<\/p>\n The only problem, Witczak told the Lever, was that Nuplazid did not work very well, if at all. In\u00a0three separate clinical trials<\/a>, Acadia Pharmaceuticals, the manufacturer, had failed to show its drug was any better than a placebo. The company then ran a fourth trial using a modified version of the standard twenty-question test for symptoms. Only this time, the test included just the questions that had shown \u201cthe most favorable change<\/a>\u201d in the previous trials. According to this measure, Nuplazid appeared to be effective.<\/p>\n Then there was the problem of deaths. Treated patients were\u00a0three times as likely<\/a> to die\u00a0as patients given a placebo. The company noted in its submission to the FDA that study investigators concluded that most deaths were \u201cunrelated or unlikely connected with the study drug.\u201d Patients on the treatment were also more prone to other serious complications, including psychiatric symptoms. Paul Andreason, the FDA scientist in charge of reviewing Nuplazid,\u00a0recommended<\/a>\u00a0against approval, citing the drug\u2019s questionable clinical trials, its \u201cminimal clinical benefit,\u201d and its \u201cunapprovable safety profile.\u201d<\/p>\n Acadia did not respond to multiple requests for comment.<\/p>\n After the public testimony, Witczak recalls that most of her fellow committee members were more interested in expressing their sympathy for patients than in considering the drug\u2019s flimsy efficacy data and poor safety record.<\/p>\n \u201cThey said, \u2018This is a serious disease. We need to have options for these patients and their doctor,\u2019\u201d she told the Lever, \u201cAs a human being, of course you\u2019re drawn to the emotional. But our job was to look at the science as well as how much need there was.\u201d<\/p>\n Witczak voted against approving Nuplazid, along with only one other committee member (who had Parkinson\u2019s disease). The remaining twelve voted<\/a> in favor\u00a0of the drug. When Andreason\u2019s supervisor overruled him and the FDA approved Nuplazid a month later, Parkinson\u2019s advocacy groups\u00a0cheered<\/a>\u00a0the\u00a0decision<\/a>. Michael Okun, national medical director of the Parkinson\u2019s Foundation, told the newsletter\u00a0Parkinson\u2019s News Today<\/a>, \u201cThe approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson\u2019s disease psychosis.\u201d<\/p>\n \u2018Some public testimony at FDA hearings is staged and manipulated by industry. . . Drug companies want advisory committees to listen to the emotions and not look at the science.\u2019<\/p>\n What Nuplazid\u2019s approval really represented was the power of pharmaceutical money to use patient advocates as proxies, says Adriane Fugh-Berman, a physician and professor of pharmacology and physiology at Georgetown University School of Medicine.<\/p>\n \u201cSome public testimony at FDA hearings is staged and manipulated by industry,\u201d she says. \u201cDrug companies want advisory committees to listen to the emotions and not look at the science.\u201d<\/p>\n An examination of\u00a0financial disclosure forms<\/a>\u00a0filed with the FDA revealed that most patients and family members at the hearing had their travel and lodging expenses covered by either Acadia or a patient advocacy group that received funding from drugmakers. The\u00a0Parkinson\u2019s Foundation<\/a>, along with other major advocacy\u00a0groups<\/a>\u00a0in favor of approving Nuplazid, including the\u00a0Michael J. Fox Foundation for Parkinson\u2019s Research<\/a>, receives\u00a0funding<\/a> from Acadia\u00a0and other drug companies.<\/p>\n Absent from the meeting were the accounts of patients who died while taking Nuplazid or were too incapacitated from the drug to share their story, as well as the vast majority of patients who likely never knew the meeting was happening. The only way many patients learn of such FDA meetings is through drug companies, which are incentivized to tap only patients who\u2019ve had successful outcomes.<\/p>\n Advocacy groups can do a great deal of good for their members, providing information to newly diagnosed patients, for example, and compiling data on disease rates and treatments. Drug companies gain insight by talking to advocates about what they need from their medicines. But the amount of money that pharmaceutical companies spend on advocacy groups \u2014 a whopping\u00a0$6 billion<\/a> to twenty-thousand-plus advocacy organizations between 2010 and 2022 \u2014 suggests there\u2019s also a financial incentive for drugmakers.<\/p>\n A database<\/a>\u00a0compiled by\u00a0KFF Health News, using publicly available tax documents, tallied $116 million in donations to patient groups in 2015 from just 14 companies \u2014 a figure that dwarfs the $63 million those same drug companies devoted that year to lobbying.<\/p>\n A\u00a0study<\/a>\u00a0led by researchers at the University of Pennsylvania found that 83 percent of the 104 largest patient advocacy groups (those with revenues over $7.5 million a year) make as much as half of their revenue in contributions from the drug industry.<\/p>\n \u201cThese companies would not be spending that kind of money and time on their relationships with patient advocacy groups if it didn\u2019t improve their bottom line,\u201d says Sharon Batt, an adjunct professor of bioethics at Dalhousie University in Nova Scotia.<\/p>\n Drug company employees with titles like \u201cdirector of patient engagement\u201d carefully cultivate relationships with advocacy groups. Some patient groups are led by executives on \u201cloan\u201d from industry, according to\u00a0a study<\/a>\u00a0published in 2020, and nearly 40 percent have a pharmaceutical executive on their boards. Another\u00a0study,<\/a> by Patients for Affordable Drugs, the rare advocacy group that does not accept money from pharmaceutical companies, found that twelve of fifteen major patient advocacy organizations have pharmaceutical industry representatives on their boards. All but one of the groups failed to fully disclose the amount of money they receive from the industry.<\/p>\n Companies offer their advocacy partners\u00a0access<\/a>\u00a0to lobbyists and public relations experts to help them with marketing and outreach \u2014 operatives who also happen to represent the companies. Meanwhile, industry scientists provide these groups information about their drugs, making patient advocates feel like they have the inside scoop on cutting-edge science \u2014 science that many people aren\u2019t equipped to understand or interpret.<\/p>\n A\u00a0best-practices report<\/a>\u00a0by a pharmaceutical consulting company based in North Carolina estimates that drugmakers devote, on average, the equivalent of six full-time positions to nurturing relationships with patient advocates.<\/p>\n Batt, a cancer survivor, patient advocate, and author of a\u00a0book<\/a>\u00a0about breast cancer advocacy and the pharmaceutical industry, says patient advocates eventually begin to internalize industry-crafted messages.<\/p>\n \u201cThe companies give them money, they train patients how to testify on behalf of industry, and help them flood the FDA with comments,\u201d she says. \u201cPretty soon, these groups are championing industry narratives. They argue that patients can decide for themselves what to put in their bodies, that newer drugs are the best drugs, that new drugs are worth it, no matter the cost.\u201d<\/p>\n Fran Visco, president of the National Breast Cancer Coalition, agrees.<\/p>\n \u201cMany patient organizations are only interested in more drugs, not better drugs,\u201d she says. \u201cI was in a science meeting and one of the participants from a patient group said, \u2018I\u2019m just trying to get more drugs into patients.\u2019 I said that\u2019s not what we\u2019re interested in. We\u2019re interested in drugs that work.\u201d<\/p>\n Putting their messages in the mouths of patient organizations is a double win for pharmaceutical companies: These groups\u00a0serve<\/a> as covert marketers\u00a0of their sponsors\u2019 drugs to a public that is largely unaware of their industry funding, so their promotional and lobbying efforts for industry-friendly legislation and drug approvals seem to be coming from an independent and highly credible source.<\/p>\n The power of these advocacy groups can also be weaponized to overwhelm the FDA.<\/p>\n In 2015, for example, patient advocates\u00a0inundated<\/a> the agency\u00a0with\u00a02,792 emails<\/a> and numerous phone calls demanding the approval of a new Duchenne muscular dystrophy drug, Exondys 51. A rare and tragically fatal genetic disorder, Duchenne afflicts mostly boys, preventing their bodies from making enough dystrophin, a protein that\u2019s necessary to keep muscles working. Most people with Duchenne must use wheelchairs as teenagers and die by age thirty.<\/p>\n The drug\u2019s manufacturer, Sarepta, provided the FDA with data showing that Exondys 51 could help patients produce dystrophin, but only in\u00a0tiny amounts<\/a> \u2014 and the data came from just twelve patients. The company\u2019s studies also failed to demonstrate that Exondys 51 provided any meaningful improvement in the boys\u2019 ability to walk. Ellis Unger, the FDA scientist in charge of reviewing the drug, shredded Sarepta\u2019s results, writing<\/a>\u00a0that accelerated approval for Exondys \u201cwould lower the evidentiary standard for effectiveness to an unprecedented nadir.\u201d<\/p>\n But Duchenne advocacy groups leaned hard on the FDA to approve the drug, meeting as many as a dozen times with Janet Woodcock, then director of the Center for Drug Evaluation and Research, and Unger\u2019s boss. Some advocates went further, their petitions verging on threats. According to\u00a0FDA documents<\/a>, one advocate wrote to then FDA commissioner Robert Califf, \u201cHow is it that everyone in and around Duchenne muscular dystrophy understands this simple idea and the science geniuses at FDA don\u2019t? You stupid f-ckers are costing each and every DMD kid days of their lives with your Moronic Dystrophin dance. Time to get a f-cking clue\u2026\u201d<\/p>\n Besides its patient advocacy champions, Sarepta had friends in high places. Rick Santorum, former Republican senator from Pennsylvania,\u00a0tweeted<\/a>\u00a0that he planned to attend an advisory meeting in support of the drug. After multiple meetings with the company, Woodcock began saying she was inclined toward approval because the company \u201cneeded to be capitalized<\/a>.\u201d A lawsuit filed by an FDA watchdog alleges that a total of\u00a0109 members<\/a> of Congress lobbied the FDA in favor of Exondys 51\u2019s approval, according to court documents reviewed by the Lever. Agency leadership approved the drug in September 2016, even after its advisory committee on the matter gave Exondys 51 a decisive 7\u20133 thumbs-down.<\/p>\n In a\u00a0formal complaint\u00a0<\/a>to his supervisors, Unger called Exondys 51 \u201ca scientifically elegant placebo.\u201d By allowing the marketing of an ineffective treatment, he wrote, the FDA was giving thousands of patients and their families \u201cfalse hope.\u201d Even worse, he added, \u201c\u2026false scientific conclusions have the potential to mislead the field of medicine, slowing progress in finding and developing therapies that actually are effective. There could also be significant and unjustified financial costs \u2014 if not to patients, to society.\u201d<\/p>\n \u2018Protecting the public from drugs that don\u2019t work is not just not rewarded, it\u2019s punished.\u2019<\/p>\n The drug is now\u00a0priced<\/a>\u00a0from $750,000 to $1.5 million per patient, and contributes to the\u00a0$1.79\u00a0<\/a>billion Sarepta makes each year from muscular dystrophy drugs.<\/p>\n Sarepta has yet to complete a controlled study showing Exondys 51 helps children with Duchenne muscular dystrophy live longer or even walk a few more steps. In response to questions, the company acknowledged it did not have data from a new clinical trial, but said it has \u201creal-world\u201d evidence<\/a>\u00a0of benefit.<\/p>\n After Unger left the FDA in 2021, he began working at a\u00a0Washington, DC\u2013based law\u00a0firm<\/a> advising drug companies on product development.<\/p>\n \u201cNo one at FDA gets rewarded for stopping a drug,\u201d says Charles Seife, a professor of journalism at New York University and longtime FDA observer. \u201cProtecting the public from drugs that don\u2019t work is not just not rewarded, it\u2019s punished. You\u2019re seen as a troublemaker. When someone does articulate concerns and the agency requires follow-up studies, it doesn\u2019t follow through. I\u2019ve never seen a bureaucracy refuse to exercise the powers it\u2019s been granted like the FDA.\u201d<\/p>\n By the time Robert Califf\u2019s name was floated in 2022 by the Biden administration as a possible candidate for FDA commissioner, trust in the agency had plummeted. Still in the grip of the COVID-19 pandemic, the public had been whipsawed by confusing and ultimately discredited FDA decisions during Trump\u2019s first tenure in the White House. By 2022, a\u00a0poll<\/a>\u00a0found that only 27 percent of the public had a \u201cgreat deal\u201d of trust in the agency and its decisions.<\/p>\n Califf was sold as the balm a pandemic-weary nation and a dispirited agency needed. He had served as FDA commissioner for eleven months<\/a>\u00a0during the Obama Administration before Trump assumed office, and he was an experienced clinical trial researcher who had joint appointments at Stanford and Duke universities. In announcing his nomination,\u00a0President Joe Biden said<\/a>, \u201cAs the FDA considers many consequential decisions around vaccine approvals and more, it is mission-critical that we have a steady, independent hand to guide the FDA.\u201d<\/p>\n The FDA may have gotten a steady hand in the seventy-year-old cardiologist, but it did not appear to get a fully independent one. According to disclosure documents<\/a> filed in July 2020, Califf had financial relationships with more than two dozen drug companies. Between his first stint as commissioner and his second, he was paid $2.7 million by Verily Life Sciences, a biomedical research organization operated by Alphabet Inc. (Google\u2019s parent company), and his portfolio<\/a>\u00a0included millions of dollars in biotech stock.<\/p>\n During his tenure, Califf presided over a series of questionable drug approvals by the FDA, including Exondys and the new Alzheimer\u2019s drugs, which\u00a0have been found<\/a>\u00a0to provide insignificant benefits with serious and sometimes deadly side effects.<\/p>\n But Califf was not the first high-level FDA official to arrive with a conflict of interest that risked influencing their regulatory decisions.<\/p>\n Daniel Troy was appointed chief counsel at the agency in 2001 by President George W. Bush after previously\u00a0suing<\/a>\u00a0the FDA on behalf of drug and tobacco companies. Once installed, Troy invited lawyers from drug and medical device companies to inform him of pending lawsuits, so his FDA office could aid in their defense. At a legal conference in 2003, he\u00a0told<\/a> industry lawyers, \u201cWe can\u2019t afford to get involved in every case. . . we have to pick our shots.\u201d To ensure that a plea would get his attention, Troy told lawyers to make their case \u201csound like a Hollywood pitch.\u201d<\/p>\n The tilt to industry-friendly FDA management began in 1969, even before the passage of the paradigm-shifting Prescription Drug User Fee Act. That year, President Richard Nixon\u00a0changed<\/a>\u00a0the role of FDA commissioner from a lifetime civil servant to a political appointee, opening the door to commissioners who could come from industry with significant financial conflicts of interest.<\/p>\n During the past two decades, seven of the agency\u2019s eight commissioners have had financial ties to pharmaceutical and\/or medical device companies. The result? FDA decisions and interpretations of legislation have increasingly benefited drugmakers at the expense of public health.<\/p>\n Take Margaret Hamburg, appointed by President Barack Obama in 2009 and hailed by public health organizations as a reformer who could \u201cfix the FDA<\/a>.\u201d Hamburg had\u00a0deep financial conflicts<\/a>\u00a0of interest with industry, which went virtually unnoticed in the press.<\/p>\n Hamburg\u2019s husband, Peter Brown, was a principal at Renaissance Technologies (RenTec), a multibillion-dollar hedge fund with large investments in numerous pharmaceutical companies. Before taking the helm at the FDA, Hamburg and Brown sold their stock in a number of the drug companies held by RenTec. But the FDA\u00a0did not investigate<\/a>\u00a0the couple\u2019s investments in RenTec\u2019s exclusive, highly lucrative Medallion Fund, which was also heavily invested in pharmaceutical companies, earning the family at least $3 million between 2009 and 2010.<\/p>\n Hamburg, who did not respond to a request for comment,\u00a0previously told<\/a> the\u00a0BMJ that the Office of Government Ethics reviewed any potential conflicts regarding their investments and did not require additional divestments.<\/p>\n During her tenure, the FDA expedited several drug approvals, despite\u00a0questionable evidence<\/a>\u00a0of their efficacy. In 2012, she shepherded a new \u201cbreakthrough pathway<\/a>\u201d for drug approvals, enabling pharmaceutical companies to secure faster approvals than ever before.<\/p>\n On paper, breakthrough status is intended for new drugs that offer a substantial improvement over existing treatments. However, a\u00a0four-year review<\/a>\u00a0by researchers at Harvard found that the breakthrough designation was awarded based on preliminary data \u201clong before the evidence to substantiate such claims is available.\u201d<\/p>\n Once FDA managers and drug reviewers leave the agency, they often\u00a0take jobs\u00a0at the very companies they previously regulated.<\/p>\n Once FDA managers and drug reviewers leave the agency, they often\u00a0take<\/a> jobs\u00a0at the very companies they previously regulated. Vinay Prasad, who is currently the FDA\u2019s Chief Medical and Scientific Officer, told\u00a0KFF Health News<\/a>\u00a0in 2016, \u201cIf you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate,\u201d Prasad said. \u201cAre you more likely to give [companies] the benefit of the doubt?\u201d<\/p>\n By 2022,\u00a0nine of the last ten<\/a> FDA commissioners\u00a0went to work for a drug company after leaving the agency. A 2018 review by the journal\u00a0Science<\/a> found that eleven of sixteen drug reviewers who left the agency between 2009 and 2018 took industry jobs. Some landed at the companies whose drugs they had recently reviewed.<\/p>\n An investigation by the BMJ found that two FDA reviewers who oversaw the approval of COVID-19 vaccines later departed to work for the\u00a0COVID-19 vaccine maker Moderna<\/a>. In 2022 and 2023, FDA administrators sent emails to several departing staffers, including the two future Moderna employees, saying they could work \u201cbehind the scenes\u201d with the agency, despite federal regulatory prohibitions on former FDA employees lobbying Congress or the agency on \u201cmatters on which they had previously worked.\u201d<\/p>\n Patrizia Cavazzoni, a psychiatrist,\u00a0left<\/a>\u00a0Pfizer in 2018 to eventually become the head of the FDA\u2019s drug division. While there, she oversaw the\u00a0controversial approvals<\/a> of the Alzheimer\u2019s drugs Aduhelm, Leqembi, and Kisunla. During the course of approving Aduhelm, an internal FDA council, which included Cavazzoni, concluded there wasn\u2019t enough evidence that the drug worked. Yet two months later, the drug was approved under her watch.<\/p>\n In an FDA statement, Cavazzoni praised Aduhelm for giving Alzheimer\u2019s patients \u201can important and critical new treatment.\u201d The company\u00a0stopped<\/a> selling the drug three years later, following a\u00a0congressional investigation<\/a> and related criticism of the FDA. Cavazzoni retired from the agency on January 18, 2025, just before Trump\u2019s inauguration. Five weeks later, Pfizer announced<\/a>\u00a0she would return as its\u00a0chief medical officer<\/a>.<\/p>\n While FDA critics have proposed multiple avenues over the years to address Big Pharma\u2019s lock on the agency, few, if any, go as far as the reforms pledged this year by Trump and Kennedy, his top health czar.<\/p>\n For example, the nine hundred\u2013page Project 2025<\/a>\u00a0plan to remake the federal government under a second Trump administration called for strict rules prohibiting outgoing FDA employees from immediately getting jobs at pharmaceutical companies. The policy agenda also targeted industry money flowing to agencies like the FDA, stating, \u201cFunding for agencies and individual government researchers must come directly from the government with robust congressional oversight.\u201d<\/p>\n Kennedy echoed these sentiments in his official\u00a0Make America Healthy Again report<\/a>, released in May 2025. The document called for the end of \u201ccorporate capture,\u201d which it defined as \u201cthe systematic distortion of scientific literature, regulatory processes, clinical practices, and public discourse by pharmaceutical and health care industries, all aimed at maximizing profits.\u201d<\/p>\n There was also hope in some quarters that Makary, the administration\u2019s choice to helm the FDA, would raise the agency\u2019s drug-approval standards. Makary, formerly a pancreatic surgeon and researcher at Johns Hopkins University Medical Center, has been so committed to improving science at the agency that he was initially a coauthor on the second part<\/a> of this investigation. (Makary previously coauthored\u00a0an article<\/a>\u00a0in a medical journal with one of the authors of this story.)<\/p>\n But Makary may be hamstrung by an administration bent on deregulation. While Trump has implemented\u00a0many parts<\/a>\u00a0of the Project 2025 agenda, such as dismantling government agencies and rolling back clean-energy initiatives, eliminating industry ties to the FDA has not been among them.<\/p>\n \u201cThe 2025 mandate is a classic bait and switch,\u201d says Jerome Hoffman, professor of medicine emeritus at the University of California, Los Angeles. \u201cThey correctly diagnose the problem and seem to propose the right solutions that make them sound like populists to get MAGA and MAHA supporters on board.\u201d But according to Hoffman, the programs they\u2019ve put in place \u201cdo just the opposite and actually reinforce the status quo\u2026 protecting pharma\u2019s profits. And if anybody complains, they will double down on their decisions and blame the media.\u201d<\/p>\n There are already signs that Hoffman may be right. Far from taking steps to reverse the damage caused by drugmakers paying user fees to the FDA, Makary supported the\u00a011.5 percent<\/a>\u00a0FDA budget cuts introduced by Elon Musk\u2019s Department of Government Efficiency, which led to\u00a0mass firings<\/a>. He then asked Congress to help offset the reductions by increasing the amount of industry user fees the agency could accept from\u00a0$3.2 billion to $3.6 billion<\/a>.<\/p>\n In July, Makary appointed George Tidmarsh to head drug approvals. Before his appointment, Tidmarsh, who has been described<\/a> as a \u201cserial entrepreneur in biopharma,\u201d headed up multiple drug companies, including Horizon Pharma. Under his leadership, Horizon patented the arthritis painkiller\u00a0Duexis<\/a>, a combination of two cheap generic drugs, ibuprofen and famotidine, and then jacked up the price. The generics cost the average arthritis sufferer $57 a month. Duexis went for\u00a0$3,064<\/a>. (While Duexis is no longer\u00a0marketed<\/a>, there\u2019s a\u00a0$25-a-month<\/a>\u00a0generic version available.)<\/p>\n This past Sunday, Tidmarsh resigned\u00a0amid allegations<\/a>\u00a0that he tried to extort and retaliate against a former business associate.<\/p>\n Makary has made some gestures toward reforms. In April, he\u00a0announced<\/a>\u00a0that the FDA would henceforth bar industry representatives from serving on its advisory committees, a move that Fox News\u00a0characterized<\/a>\u00a0as a \u201cmajor new policy aimed at limiting conflicts of interest.\u201d In reality, industry representatives have never been voting members, and Makary failed to address the extensive financial conflicts of interest among committee members who do vote on drug approvals.<\/p>\n The Lever\u00a0reviewed the financial ties of one of the most active panels, the oncology committee, which reviews cancer drugs. Before Makary assumed his post, eight of nine voting panelists had financial ties to industry. When the agency assembled a new oncology committee in late May, nine of eleven voting members received money from drugmakers \u2014 and in greater amounts than those on the earlier panel. The highest-paid member of the earlier panel received\u00a0$189,216<\/a>\u00a0in drugmaker payments, including consulting and speaking fees, since 2018, while the highest-paid member of the new panel netted\u00a0$301,824<\/a>\u00a0in drugmaker payments over the same period.<\/p>\n Now, all such advisory committees, which have served as one of the few public windows into agency decision-making and a check on FDA missteps, may be a thing of the past. Before his resignation, Tidmarsh told industry executives that he views such committees as \u201credundant<\/a>\u201d for individual drug approvals. Meanwhile, Makary launched a series of controversial\u00a0ad-hoc expert panels<\/a>\u00a0on topics like hormone therapy and antidepressants, several members of which have\u00a0financial ties<\/a>\u00a0to the drug industry.<\/p>\n Makary\u2019s FDA has turned down a handful of drug applications this year, to the\u00a0consternation<\/a> of Wall Street, but at other times, the agency\u2019s efforts to use sound science have been thwarted. Elevidys, a gene therapy for Duchenne muscular dystrophy patients who can still walk, was approved in June 2023 under the Biden Administration, despite the drug\u2019s clinical trial having \u201cfailed to demonstrate<\/a>\u201d the treatment worked. Sarepta, the company behind Elevidys, began marketing the treatments last year at\u00a0$3.2 million per<\/a>\u00a0patient.<\/p>\n In late July, Prasad, an oncologist chosen to head the FDA\u2019s approval of biologic drugs,\u00a0paused<\/a>\u00a0Elevidys sales as one of his first moves at the agency,\u00a0<\/a>after three people, including an eight-year-old boy, died of liver failure after getting the treatment. Two days later, Prasad \u2014 who has previously\u00a0coauthored<\/a>\u00a0an article in a medical journal with one of the authors of this story \u2014 was forced out by Trump, reportedly on the advice of far-right social media influencer Laura Loomer, who\u00a0denounced<\/a> him\u00a0as a \u201cprogressive leftist saboteur.\u201d<\/p>\n But in reality, there had been industry pressure behind the scenes. Sarepta and several current and former lawmakers \u2014 including Santorum and Senator Ron Johnson (R-Wisc.) \u2014 complained<\/a>\u00a0to the White House about the hold on Elevidys. The patient advocacy group Parent Project for Muscular Dystrophy, which has\u00a0financial ties to Sarepta<\/a>, also\u00a0urged<\/a>\u00a0the FDA to allow sales to proceed, stating that \u201cfamilies are willing to accept substantial risk.\u201d<\/p>\n Prasad was soon\u00a0reinstated<\/a>, but the FDA also lifted the hold on sales of Elevidys. Meanwhile, the agency has approved at least two other drugs with little evidence that they work.<\/p>\n In May, regulators authorized Welireg, a tumor drug, based on an\u00a0incomplete and preliminary<\/a>\u00a0study. Then, in September, the agency endorsed Forzinity, a drug for a rare condition called Barth syndrome, even though the FDA staffer who reviewed the single study submitted with the application\u00a0concluded<\/a>\u00a0it \u201cdoes not meet the statutory requirement of substantial evidence of effectiveness, even in the context of a rare disease.\u201d<\/p>\n Makary has also\u00a0rolled out<\/a>\u00a0a new\u00a0National Priority Voucher program<\/a>\u00a0that promises to reduce the review timeline for selected drugs to as little as one month.<\/p>\n Speeding up<\/a> approvals\u00a0is \u201cnot always better, and sometimes worse,\u201d says Rita Redberg, a cardiologist at the University of California, San Francisco, and former editor-in-chief of\u00a0JAMA Internal Medicine. \u201cWe do not want to rush dangerous drugs and devices to the market.\u201d Tidmarsh, the former head of the FDA\u2019s drug division,\u00a0told<\/a> the\u00a0New York Times\u00a0that he faced agency pushback leading up to his resignation because he criticized the new voucher program for injecting politics into drug reviews.<\/p>\n The National Priority Voucher program and other FDA actions have left many experts discouraged about the agency\u2019s prospects for reasserting its regulatory power and halting the influx of questionable drugs onto the market.<\/p>\n \u201cIf you have diminished public input, less FDA capacity, and you\u2019re bringing in folks that are deregulatory and industry oriented, the agency, in effect, is not going to be acting as a regulator,\u201d said Yale\u2019s Ramachandran. \u201cIt is essentially going to be a rubber stamp.\u201d<\/p>\n This arrangement may suit many drug companies. The industry continues to fill congressional campaign coffers<\/a>\u00a0and deploy an\u00a0army of lobbyists<\/a>\u00a0to influence votes on legislation favored by industry. It spends even more money currying favor not just with patient advocacy groups, but also with medical professionals.\u00a0Nearly 60 percent<\/a>\u00a0of the country\u2019s doctors received payments from drug and medical device manufacturers between 2013 and 2022, with more than $12 billion changing hands. Big Pharma also gives an undisclosed amount to physician groups like the American Medical Association.<\/p>\n Pharmaceutical companies also devote\u00a0millions<\/a> of dollars to so-called feel-good or unbranded advertisements, with tag lines like \u201cDriven to the cure<\/a>\u201d and \u201cYou\u2019ll get better.<\/a>\u201d Instead of marketing specific drugs, such advertisements are designed to burnish the industry\u2019s reputation for caring about patients \u2014 and by extension, casting doubt on regulators who rule against their products.<\/p>\n The industry will find ways to achieve its goals unless Congress passes stronger regulatory measures \u2014 a scenario that seems unlikely without campaign finance reform and a change in administration.<\/p>\n In 2021, the top five unbranded pharmaceutical marketing campaigns \u2014 such as Abbott Laboratories\u2019\u00a0$66 million<\/a>\u00a0\u201cHealth and Human Dignity<\/a>\u201d campaign \u2014 totaled $216 million.<\/p>\n \u201cBig Pharma has mastered the art of controlling perception and controlling the narrative,\u201d says Witczak, the former FDA drug advisory committee member. \u201cThe industry shapes what everybody, from Congress to the media to doctors and patients, believes.\u201d<\/p>\n Ultimately, the industry will find ways to achieve its goals unless Congress passes stronger regulatory measures \u2014 a scenario that seems unlikely without campaign finance reform and a change in administration.<\/p>\n
\nFor every dollar the pharmaceutical industry spends on lobbying Congress and donating to campaigns, it devotes even more to influence\u00a0physicians<\/a>\u00a0and\u00a0patient advocacy groups<\/a>, which mount pressure campaigns and lobby regulators on behalf of questionable medicines and laxer drug standards.
\nTop drug regulators routinely leave the FDA for\u00a0lucrative jobs<\/a>\u00a0in the industry, meaning their career goals could potentially influence their regulatory decisions. At the same time, drug company executives cycle into high-level FDA jobs, where they\u2019ve been known to implement pro-industry policies and drug approvals.<\/p>\n