The bad behavior in the drug industry that has gotten the most attention is price gouging on brand name drugs. However, the bad behavior is more pervasive than just that.
The solution to price gouging on brand name drugs has typically been to wait for their patents to expire and assume that competition from generic drug makers would then drive prices down. The pharmaceutical industry has fought back against this by finding ways to extend their patents, for example by tweaking their drugs or the way they are delivered (e.g., pill, gel, slow-release formulation, etc.). The brand name drug makers have also paid generic drug companies not to release generic versions of their drugs. (See my previous posts on 1/2/18 and 1/13/18 for more detail.)
Recently, it’s come to light that generic drug makers have apparently been engaged in “illegal price-fixing schemes of massive proportion.” [1] An anti-trust lawsuit based on two drugs began in 2016 and has now grown to include 300 drugs and 16 generic drug makers. Consumers, health insurers, hospitals, and taxpayers have been paying illegally set high prices for antibiotics and medications for diabetes, asthma, high blood pressure, arthritis, anxiety, and much more.
The alleged collusion appears to have transformed the generic drug industry from a highly competitive and price-driven business into one where coordinated price increases occur regularly for identical or similar drugs. These price increases occur for no reason (other than greed) and are reminiscent of price hikes by brand name drug makers. However, in the case of generic drugs, claims of high research and development costs are irrelevant and big price increases shouldn’t be possible because they aren’t protected by drug patents.
For example, the cost of insulin, the life-saving drug used to manage diabetes, doubled between 2012 and 2016. Price increases occurred in a near lockstep manner across different manufacturers and different types of insulin. In January 2019, one drug maker’s prices on its insulin products increased by between 4.4% and 5.2%, while another manufacturer, simultaneously, raised its insulin prices by 5.2%. [2] In another example, Albuterol, a decades-old generic asthma medication sold by drug makers Mylan and Sun, saw its price from both manufacturers jump simultaneously from 13 cents a tablet to $4.70. (Price spikes in other generic drugs, such as the EpiPen, were highlighted in previous posts on 9/22/16 and 10/16/16.)
Generic drugs are a $100 billion a year business and represent 90% of all prescriptions. Therefore, the costs of this price fixing are undoubtedly in the billions of dollars. Forty-seven states are now plaintiffs in the expanding civil lawsuit, where new information keeps emerging and defendants are being added. Two former executives of Heritage Pharmaceuticals have pled guilty and are cooperating with prosecutors in a parallel federal criminal case.
On a different front, bad behavior in the marketing of brand name opioids is the target of increasing legal action. Executives of Insys Therapeutics are facing federal charges of racketeering, conspiracy, and mail fraud for their tactics in selling highly addictive fentanyl spray. They are charged with conspiracy to bribe and incentivize doctors, clinicians, pharmacists, and other medical professionals to prescribe the powerful opioid, including to patients who did not need it. Insys employees also contacted insurers, fraudulently claiming to be employees of medical practitioners, to lie about patients’ conditions so the insurer would pay for their fentanyl. Two executives, the former CEO and the head of sales, have pled guilty and are cooperating with prosecutors. Several doctors, a physician’s assistant, a nurse, and a former Insys sales representative (the CEO’s wife) have already been convicted. Insys has agreed to pay $150 million to settle civil and criminal charges. [3]
Purdue Pharma, the maker of OxyContin, misled prescribers and patients about the risk of addiction to OxyContin and worked to blame patients for becoming addicted. It engaged in a sophisticated and extensive marketing campaign that “educated” doctors about undertreatment of pain. It failed to report illegal activity, including blatant over-prescribing of OxyContin that clearly indicated sales in the black market. The company and three executives pled guilty in 2007 to federal charges of fraudulent marketing, with the company paying $600 million in fines.
There are scores of on-going lawsuits by states, local officials, and individuals against Purdue and other opioid makers. The Massachusetts Attorney General’s lawsuit and investigative reporting by the media are publicly revealing evidence against Purdue that was previously kept secret under plea deals engineered by Purdue and its executives. [4]
Learning the full truth about the marketing of opioids by U.S. drug makers still has a long way to go. We know enough to conclude that tens of thousands of lives could have been saved if our drug makers had not engaged in fraudulent practices or if information from earlier court cases had been made public instead of being kept secret under the terms of plea deals. [5] (See previous posts on the opioid crisis and drug makers here, here, here, and here, with a post on solutions here.)
Patients in the U.S. bought $430 billion of prescriptions drugs in 2018 that probably would have cost less than $80 billion in a truly free market, without patents and other constraints. This $350 billion difference is five times what we spend on food stamps, over eight times what the federal government spends on K-12 education and two-thirds of all state and local spending on K-12 education, and over 20 times what the federal government spends on Head Start and child care combined. [6]
Clearly, the prescription drug market in the U.S. is ineffectively regulated. Drug manufacturers have such huge profit margins that there are enormous incentives to use fraudulent methods to increase drug sales. These methods include bribing those who write prescriptions, misrepresenting the safety and effectiveness of drugs, pushing their inappropriate use, and more. This type of inappropriate, aggressive marketing is a major cause of the opioid epidemic and thousands of deaths. Predatory price increases and illegal price fixing by drug manufacturers are costing consumers, health insurers, and others billions of dollars a year that are pure profit for the pharmaceutical industry.
My next post will present steps that can be taken to control drug costs.
[1] Rowland, C., 12/10/18, “Price-fixing probes on drugs expand,” The Boston Globe from The Washington Post
[2] Silverman, E., 1/25/19, “Feeling the needle,” The Boston Globe
[3] Cramer, M., 1/10/19, “Former CEO pleads guilty to conspiracy in fentanyl marketing,” The Boston Globe
[4] Joseph, A., 1/16/19, “Opioid maker sought to put blame on addicted,” The Boston Globe
[5] Meier, B., 12/26/18, “Opioid makers are the big winners in lawsuit settlements,” The New York Times
[6] Baker, D., 1/14/19, “Three Bernie Sanders bills to arrest the highway robbery in the prescription drug market,” The American Prospect (https://prospect.org/article/three-bernie-sanders-bills-arrest-highway-robbery-prescription-drug-market)
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