Rethinking Medications: Uncovering the Truth About Common Drugs

Interview with The People’s Pharmacy

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Abstract

"Americans spend more on drugs and have less to show for it than people in other countries. The FDA used to be the envy of the world. Has it been captured by the pharmaceutical industry it's supposed to regulate?"

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In this wide-ranging episode of The People's Pharmacy — one of the most substantive and practically useful interviews in the archive — Dr. Jerry Avorn joins hosts Joe and Terry Graedon for a 70-minute conversation covering the erosion of FDA standards, the structural causes of high drug prices, the difference between relative and absolute risk, the nocebo effect, the importance of brown-bag medication reviews, the crisis in primary care, and the questions every patient should ask before starting or stopping a medication.

How the Pharmaceutical Industry Has Changed

Dr. Avorn acknowledges that the science of drug development has become more impressive than ever, both within industry and within academic medical centers. But he argues that the business side of the industry has expanded in ways that have brought enormous political pressure to bear on the FDA. The pharmaceutical industry has become the most powerful lobbying entity in Washington, with more lobbyists than there are members of Congress, and that pressure — applied across both political parties and multiple administrations — has gradually tilted FDA decision-making away from rigorous science and toward industry accommodation.

The Erosion of FDA Approval Standards

Dr. Avorn traces the current weakening of FDA standards to a well-intentioned decision in the early 1990s: the creation of the accelerated approval pathway at the height of the AIDS epidemic, when no good treatments existed and urgency was genuine. The pathway allowed drugs to be approved based on promising early signs, with follow-up studies to be completed afterward. "That was a sensible idea back in the early nineties," Dr. Avorn says. But the pathway has since been widened far beyond what anyone intended. It is now being used to approve drugs for conditions such as ALS and muscular dystrophy on "the scantiest of evidence," with companies often failing to complete the promised follow-up studies. The result is medications on the market that have not been shown to help patients, presenting costs and risks without corresponding benefits.

The most egregious example Dr. Avorn cites is Aduhelm, the Alzheimer's drug approved over the objections of outside advisors and FDA's own scientific staff. Aduhelm did not benefit patients clinically, carried substantial side effects, and was initially priced at $56,000 per year for intravenous infusions every other week. It has since been withdrawn from the market. Dr. Avorn describes it as "really kind of the low point of FDA's recent history."

More broadly, he argues that the FDA has shifted its standard from "does it help patients?" to "does it make a lab test look a little better?" — a change he calls a fundamental departure from what the agency was designed to do.

Safe and Effective: What Those Words Really Mean

Dr. Avorn explains that the FDA's definitions of "safe" and "effective" differ substantially from what most patients assume. "Safe" does not mean without risk — every drug can cause serious side effects in some people. What the FDA is supposed to certify is that the drug's benefits substantially outweigh its risks in the population for which it is indicated. "Effective" does not mean dramatically better than existing alternatives — it means better than placebo, a bar that can be cleared by drugs with only marginal real-world benefit. Dr. Avorn argues the FDA needs to return to asking whether a drug actually helps patients, not merely whether it moves a laboratory measurement.

Absolute vs. Relative Risk: A Critical Distinction

One of the most practically important segments of the interview concerns how drug companies present effectiveness data. Dr. Avorn and the hosts use the famous Lipitor advertisement as their central example. The ad claimed Lipitor reduced the risk of heart attack by 36% — a figure that is technically accurate as a relative risk reduction. But in the underlying trial, 3% of placebo patients had heart attacks over five years, compared to 2% of Lipitor patients. The absolute risk reduction was 1 percentage point — one fewer heart attack per hundred patients over five years. Dr. Avorn argues that doctors are not adequately trained to think about the difference between these two ways of expressing the same data, and that patients deserve to understand it. Drug companies, he notes, prefer relative risk reduction because it produces larger and more impressive-sounding numbers.

The Nocebo Effect and Side Effect Reporting

Dr. Avorn describes a groundbreaking study conducted by his group comparing the placebo side-effect profiles in clinical trials of tricyclic antidepressants versus SSRI antidepressants. Since participants in both groups were receiving identical dummy pills, there should have been no difference in reported side effects. Yet the placebos in tricyclic studies and the placebos in SSRI studies had dramatically different side effect profiles — closely mirroring the known side effects of the active drugs being studied in each trial. This finding illustrates the nocebo effect: patients who expect to experience certain side effects may in fact experience them, even from a placebo. The implication is that the way researchers ask about symptoms, and patients' prior expectations, can significantly influence reported side effect rates — a consideration relevant to interpreting drug safety data.

The hosts illustrate this with a striking real-world example: semaglutide, which is marketed as both Ozempic (for diabetes) and Wegovy (for weight loss). In Ozempic trials, 20% of patients reported nausea; in Wegovy trials, 40-44% did — nearly twice as many, despite the active ingredient being identical. More striking still, nausea in the placebo group was reported by 6.1% of Ozempic trial participants and 16-18% of Wegovy trial participants — again, dramatically different rates for a dummy injection. Dr. Avorn notes this difference likely reflects differences in underlying patient populations and in how researchers elicited symptoms, and that it illustrates the importance of rigorous randomized controlled trials with carefully standardized methods.

Direct-to-Consumer Advertising

The United States and New Zealand are the only wealthy industrialized countries that permit pharmaceutical companies to advertise prescription drugs directly to consumers. Dr. Avorn traces the change in US policy to 1997, when the FDA reversed a longstanding prohibition. He explains that the industry had initially accepted the ban — prescription drug advertising is expensive, and companies were content not competing for television airtime alongside shampoo and car commercials. The change came with the rise of managed care in the 1990s, when health maintenance organizations began refusing to cover drugs they deemed overpriced or no better than existing alternatives. Facing formulary restrictions for the first time, the industry saw an opportunity: turn every patient into a potential sales representative by advertising directly to them, then have them go to their doctors and request specific drugs by name. "In 1997, for the first time ever, the FDA said, okay, it's all right for there to be direct-to-consumer drug ads," Dr. Avorn says — "alone in the entire world." He does not believe this has improved prescribing or public health, and notes that the billions of dollars spent on consumer advertising are passed on directly to drug prices.

Why Drug Prices Are So High

Americans spend twice per capita what citizens of other wealthy countries spend on medications — whether in Canada, England, Japan, Australia, or across Europe — for the same drugs, made by the same companies, in the same factories. Dr. Avorn identifies the structural cause: the United States is the only country that allows drug companies to set their own prices without meaningful government pushback. When Medicare began covering prescription drugs in the early 2000s, the legislation explicitly prohibited price negotiation — a provision championed by Congressman Billy Tauzin, who subsequently left Congress to head the pharmaceutical industry's lobbying organization at a reported salary of $1 million per year. The result is a system in which, as one drug company CEO put it bluntly when asked how he could raise a drug's price by thousands of percent: "Because I can."

Dr. Avorn is careful to say he does not want to bankrupt the pharmaceutical industry. Companies that discover genuinely important drugs deserve to be richly rewarded. But his group at Harvard has shown that the price of a drug is often utterly unrelated to whether it adds anything new for patients — a mismatch that the current pricing system has no mechanism to correct.

Orphan Drugs

The Orphan Drug Act of 1983 was designed to offer incentives — tax breaks, patent extensions, and market exclusivity — to encourage companies to develop drugs for rare diseases that would otherwise have "limited commercial value." The reality has been very different. Orphan drug status is now sought for cancer drugs and other treatments by structuring the FDA application narrowly enough that fewer than 200,000 Americans per year are covered, even for conditions that are actually relatively common. The result is drugs with orphan drug protections that generate billions of dollars in annual revenue, priced at hundreds of thousands of dollars per patient per year.

The PDUFA User Fee Problem

Dr. Avorn returns to the structural conflict created by the Prescription Drug User Fee Act of 1992: the pharmaceutical industry now pays approximately half of the salaries of the FDA scientists who review their products. "That is going to make not only make drugs harder to afford," he says, but it also creates an agency that is financially dependent on the industry it regulates. The FDA was already understaffed before recent cuts; the draconian reductions now being made to FDA, CDC, and NIH staffing threaten the entire drug evaluation and post-market surveillance enterprise.

NIH Funding Cuts: The Downstream Danger

What frightens Dr. Avorn most is the ongoing cuts to NIH funding. His group at Harvard has documented that the majority of the most important breakthrough drugs had their origins in NIH-funded research at universities and academic medical centers — not in pharmaceutical company laboratories. Cutting NIH funding does not affect drug prices or drug approval next month. But in 2027 and beyond, the basic science pipeline from which new drugs emerge will have been "shut down or at least crippled." "And then sometime around 2027, people might say, hey, where's all these new pharmaceutical wonders that we were expecting? They're not going to be there."

Generic Drug Supply, Inspections, and Tariffs

More than 90% of generic medications sold in the United States are manufactured in India and China. Dr. Avorn raises three interconnected concerns. First, FDA has never had adequate budget to inspect foreign manufacturing facilities at the rate needed to ensure consistent quality. Second, if tariffs are applied to pharmaceutical imports from India and China, generic manufacturers operating on thin margins may simply stop producing drugs for the US market — worsening already serious drug shortage problems. Third, reduced FDA staffing means reduced inspection capacity at exactly the moment supply chain vulnerability is increasing.

What Patients Should Do: The Brown Bag Review and Key Questions

The most practically actionable segment of the interview concerns what individual patients can do to protect themselves. Dr. Avorn's primary recommendation is the brown bag review: periodically collecting every medication you take — prescription drugs from all your doctors, over-the-counter medications, dietary supplements, herbal remedies — and bringing them to your primary care physician for a comprehensive review. Doctors frequently discover duplications, dangerous interactions, drugs that were supposed to have been discontinued, and combinations that no single prescriber was aware of. Dr. Avorn has found prescriptions for drugs from multiple doctors where patients were unknowingly taking three different forms of the same class of anti-inflammatory medication simultaneously.

Before starting any new medication, Dr. Avorn recommends patients ask: What is this medication for? Do I take it forever or only until my symptoms resolve? What side effects should I watch for? Is there a more affordable alternative that would work just as well? And what is the goal — what will success look like, and how will we know when we've reached it?

Before stopping any medication, he stresses the equal importance of understanding how to discontinue safely. Many medications — including antidepressants — cannot be stopped abruptly without serious consequences. The emerging field of deprescribing, while valuable, requires the same rigor as prescribing: randomized trials have shown that some patients do well when antidepressants are tapered, while others relapse, and no one can predict in advance which category a given patient falls into without careful monitoring.

The ACE Inhibitor Example

Dr. Avorn and the hosts discuss a concrete illustration of how medication side effects go undetected in a fragmented healthcare system: approximately 15% of patients on ACE inhibitors — a widely used class of blood pressure medications — develop a chronic cough as a side effect. Patients are frequently worked up for allergies, asthma, acid reflux, and lung disease before anyone identifies that their blood pressure medication is the cause. A simple question from a primary care physician — are you taking an ACE inhibitor? — would identify the problem immediately. Alternatives, such as angiotensin receptor blockers, do not carry the same risk.

The Role of Pharmacists

Dr. Avorn argues that pharmacists are among the most valuable and underused professionals in the healthcare system. He envisions pharmacists embedded within primary care practices as part of the clinical team — able to catch dangerous drug interactions in real time, consult with prescribers directly, and serve as knowledgeable intermediaries between patients and physicians. The current model, in which chain drugstores optimize for throughput and pharmacists are left holding the bag when a dangerous interaction flag fires and the prescriber cannot be reached, squanders an enormous resource.