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President Trump continues to tout the benefits of the drug hydroxychloroquine, despite the FDA warning against its use to treat COVID-19.
The American Prospect does not endorse any of the following treatments.
When COVID-19 first hit America and started spreading, Dr. David Brownstein, owner of the Center for Holistic Medicine in West Bloomfield, Michigan, thought he could help. For 28 years, he’d been successfully treating flu and pneumonia through boosting patients’ immune systems with vitamins and minerals. Coronavirus was a completely different pathology, deadlier and more mysterious. But Brownstein wasn’t inclined to give up on his patients. “I told my staff, ‘I’m working till I either get sick or they don’t let me,’” he said.
In the snow and sleet of a Michigan March, Brownstein and his team administered the therapy through an IV to patients pulling up in their cars. And soon, patients who were having trouble began breathing easily. Brownstein started collecting testimonies of their experiences and posting them to his website. He marketed it as an immune support therapy, not a cure. But before long, Brownstein found something in his mail he’d never seen before—a cease and desist letter from the Federal Trade Commission. Advertising a coronavirus treatment without randomized clinical trials, a costly undertaking, violates FTC regulatory standards.
The FTC has had to make numerous rulings on COVID-19 treatments since the pandemic began, and countless business schemes and politicized hype have given them ample reason to exercise caution. President Trump continues to tout the benefits of hydroxychloroquine, despite the FDA warning against the malaria drug and documented deaths from misuse. Alex Jones marketed toothpaste as a miracle cure. The list of fake tests, snake oil treatments, and hoaxes is astoundingly long.
It’s genuinely difficult, between the novel virus and abundant misinformation, to understand where the truth lies. Federal regulators have muddled through; approvals of existing drugs like HIV/AIDS treatment remdesivir and the steroid dexamethasone have reduced the death rate, and many quack therapies have been pushed off the market. But hanging over the tougher calls is the monopolistic, agenda-setting power of the nation’s largest pharmaceutical companies. And they don’t exactly have a sterling track record.
In 2019 alone, the pharmaceutical/health products lobby spent $295 million, nearly double the next-highest spender, electronics manufacturing and equipment. For each member of Congress, there are 2.7 pharmaceutical/health products lobbyists. And they get the job done.
Industry lobbyists nixed a provision in the CARES Act that threatened intellectual-property rights and added their own provision that prevented the delay of a medicine’s development should the government raise concerns regarding affordability. While Republicans pine for liability protection for businesses that infect customers or employees with COVID-19, the drug industry already got it, immunizing themselves from any “money damages in court” over medical countermeasures for the virus. Last year, a bipartisan bill aimed to cap yearly drug price increases and restrict out-of-pocket expenses for Medicare beneficiaries died in the Senate, after the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group put their money against it.
Before coronavirus stood as the nation’s primary public-health concern, drug lobbyists rallied to keep opioids in the hands of the American public, despite evidence of addictive potential and deadly harms. Reps. Hal Rogers and Mary Bono proposed a bill in 2013 calling on the FDA to limit the prescription of opioids for “moderate” pain, only for it to die in Congress after industry-funded groups lobbied against it.
This impact on policy extends to the practices of the nation’s hospitals. “Companies selling opioids had an impact on how pain was treated,” said Joel Lexchin, a pharmaceutical policy expert with the University of Toronto. A medical trend, pushed by the drug companies, that treated pain as a “vital sign” rather than a symptom led to doctors prescribing more opioids. The proliferation of opioids grew, Lexchin added, when companies promoted their products through persistent campaigns targeted at doctors, as Purdue Pharma did with its leading opioid drug OxyContin.
While the $10 billion spent by the industry on marketing and advertisements catches the attention of most of the American public, it’s the $20 billion spent persuading doctors of a drug’s benefits which creates the greatest sway through the medical industry. It starts early, as students train to become doctors. Seventy-two percent of medical students recall over 20 instances of pharmaceutical marketing exposure during their preclinical training. In a given year, some students reported receiving an average of six gifts, 70 industry-sponsored lunch invitations, and roughly 75 promotional items. Some companies even paid for textbooks and offered drug samples. And these lobbying efforts produce results. Eight studies found a correlation between frequency of contact and favorable attitudes toward industry interactions.
As doctors advance in their careers, they are enticed with speaking fees to promote and prescribe pharmaceutical products. These same companies also send individual representatives to hospitals to tout their latest drug. Approved drugs pushed in hospitals are always backed by randomized controlled trials and the latest research. Yet some of these studies fail to provide a totality of the drug’s effects.
The average FDA approval process totals roughly $19 million, exceeding the budgets of many small drug companies and independent researchers.
Take the case of the flu drug Tamiflu, released by Swiss pharmaceutical company Hoffmann-La Roche. The drugmaker legally withheld over 150,000 pages of findings during clinical trials of Tamiflu exposing the drug as less effective and potentially harmful. Researchers from Harvard and the University of Toronto found that 85 percent of industry-funded drug trials produced positive findings, as opposed to 50 percent of government-funded trials. These results show up in medical literature, but in a selective fashion. “There is a lot of cherry-picking of which data they want to be seen out there,” said Marc-André Gagnon, who teaches pharmaceutical policy at Carleton University.
The deep pockets of these companies give them a built-in advantage. The average FDA approval process totals roughly $19 million, exceeding the budgets of many small drug companies and independent researchers. Yet there remain few alternative avenues. To bring a drug to market, smaller companies often sell the rights to their product to one of the industry giants, like Johnson & Johnson or Pfizer. This phenomenon is so common that 81 percent of products distributed by those two companies originated from third-party producers. “If it’s not a patentable product, no one will be behind it,” Gagnon explains.
But for all the assumed integrity of the system, drug giants have a safety valve not available to smaller counterparts: They can petition for an emergency use authorization (EUA) from the FDA before the randomized controlled trial concludes. This is how both remdesivir and convalescent plasma were approved for use against COVID-19. Amid widespread fears that President Trump would rush a vaccine to market as an “October surprise” before the election, nine large COVID vaccine manufacturers signed a pledge to abide by the highest scientific standards before bringing any medication to market. But critically, the signers didn’t deny that they might seek an EUA, circumventing the trial process thought to be so sacrosanct throughout the medical profession.
Compare this to complementary and alternative medicine (CAM) treatments like Brownstein’s, which aim to boost the immune system and overall health through proper diet and the use of vitamins, minerals, and herbs. Most physicians say they discuss CAM treatments with less than a quarter of their patients, and some even equate it to “witchcraft.” And there is a fair bit of pseudoscience under that banner. Yet CAM providers have little opportunity to pursue costly FDA approval, and even less opportunity to end-run it with an EUA. They do not have the resources to fund private research, or get academics to manipulate their data. They have no ability to persuade doctors to prescribe their treatments through what amounts to bribery. They have no multimillion-dollar marketing budget or lobbying army.
There’s a history to this unlevel playing field. In 1907, John D. Rockefeller worked to expand his monopolistic power from oil to health care upon the discovery of “petrochemicals” used to make certain drugs. During this time, holistic medicine was widely applied across the medical industry. Rockefeller donated over $100 million to various universities and hospitals to support centralization of the medical system, which led to stringent guidelines for medical professionals. While this was necessary in some sense for public safety and efficacy, holistic medicine soon fell out of the mainstream and drug companies bolstered by patent monopolies thrived.
While a number of questions remain surrounding CAM treatments, their potential benefits, low relative cost, and sustainable properties offer enough positive effects to entice 36 percent of Americans to currently use them. Yet until they’re thoroughly tested and tried by mainstream practitioners, they stand transfixed in a state of uncertainty. The pharmaceutical industry doesn’t have that problem.
