More reasons to be skeptical about drugs

The British Medical Association awarded Dr. Peter C. Gøtzsche first prize in the “basis of health care” category for his book, Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare. Among other things in this book, he enumerates the corrupt practices of pharmaceutical companies. Here’s a chart that summarizes the type of behaviors for which the companies were required to pay fines.

Company	Year	Fines (million dollars)	Type of wrong doing
Abbott	2003	622	Illegal marketing
	2012	1500	Fraud; Illegal marketing; bribery
AstraZeneca	2003	355	Fraud
	2010	520	Illegal marketing; bribery
Bristol-Myers Squibb	2003	670	Fraud
	2007	515	Illegal marketing; bribery
Eli-Lilly	2009	1400	Illegal marketing; fraud
Glaxo-SmithKline	2004	175	Blocking of marketing
	2006	3100	Corruption
	2009	750	Fraud
	2011	3000	Illegal marketing; fraud
Johnson & Johnson	2012	1100	Illegal marketing
Lundbeck	2013	126	Violation of the Cartel Law
Merck	2007	670	Bribery of doctors and hospitals; fraud
Novartis	2010	423	Illegal marketing
Pfizer	2009	2300	Fraudulent marketing
Purdue Pharmacy	2007	635	Lies about their drugs
Schering-Plough	2004	346	Kickbacks
Serono Lab	2006	740	Corruption
Tap Pharmaceuticals (Abbott)	2001	875	Fraud

To corroborate, an outfit called Access to Medicine Index, which independently ranks pharmaceutical companies’ efforts to improve access to medicine in developing countries, states, “18 out of 20 companies were the subject of settlements or fines for corrupt behaviour, unethical marketing or breaches of competition law. Collectively, companies were found to have been accountable for almost 100 separate breaches...The majority of these (89%) concerned improper marketing, bribery and corruption."

OK. I’ll let this drug business go. I have barely touched the subject, but you get the idea.

Next week: Think twice before getting scans and x-rays

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An example of drug sales run amok

As I write this, over 81,000 pharmaceutical representatives or 1 for every 7.9 physicians are fanning out across the United States trying to make their sales quotas. The more they sell, the bigger their bonuses.

In a book titled Blood Medicine: Blowing the Whistle on one of the Deadliest Prescription Drugs Ever, author Kathleen Sharpe provides an inside look into how Ortho, a division of Johnson and Johnson, sought to increase profits at the expense of patients. In this case, the drug they are pushing is called Procrit. The book was inspired by a whistle-blower lawsuit by two company employees, one of whom stated, “I want to be a millionaire.”

Even though the book focuses Ortho/Johnson & Johnson, I have no doubt that nearly all—if not all—of the big drug companies use many of the sales tactics described in the book, which include giving good deals to buyers (including free samples), plying them with gifts and “grants,” getting them to prescribe a lot, getting them to prescribe higher than recommended doses—whatever it takes. Here are a couple of quotes to give you the idea of the salespeople’s tactics:

“[McCellan, a salesman] started the day by bringing his boss along on a visit to Dr. Suresh Katakkar, who was set to buy $900,000 worth of Procrit that year. The doctor warmly greeted McClellan. A few weeks earlier, on April 12, McClellan had given him an Ortho check for $19,278.73—the physician’s bonus for exceeding his first-quarter purchase agreement.”

A dialogue between one salesman, named Duxbury, and his boss, goes like this: “’We’re giving them free Procrit, knowing they’re going to file for government reimbursement,’ he said. ‘Isn’t that Medicare fraud?’ ‘No,’ his boss replied. ‘All you’re doing is giving them Procrit. If they want to bill for the drug, that’s their business.’ …[Later they learn] the administrator had filed a Medicare claim based on its retail price, and presto! The federal government had actually paid for the free drugs at 95 percent of the inflated AWP [average wholesale price] price. That was pure profit, the administrator exclaimed. Duxbury reported back to Nelson, ‘They’re very happy to be making such good money on Procrit.’”

“[Duxbury] figured epo [the generic term for Procrit] had killed half a million people over the years, yet he couldn’t comprehend why the drug was still on the market approaching $100 billion in global sales… paying hundreds of millions to doctors every year to pump anemic patients with unsafe doses. In fact a cancer clinic near Seattle had received $2.7 million from Amgen [another company selling the drug] just for prescribing $9 million worth of its drug in 2006 alone.”

Next week: More reasons to be skeptical about drugs

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.

Passing off marketing as education

Big pharma spends billions each year on “education,” a program that comes out of their marketing budgets. The education is aimed at both doctors and the public, supposedly to inform them and you about drugs. Of course there’s an inherent conflict of interest between selling products and evaluating them. For example, it's highly unlikely that Pfizer would provide impartial information when comparing its anti-depression drug, Zoloft, with Paxil, which is manufactured by GlaxoSmithKline.

Plus, by “educating” doctors about off label uses for their drugs, the companies can get around the legal constraints prohibiting them from marketing drugs for unapproved uses, as required by the FDA. Doctors do not suffer the same restraints. If they can be convinced to use a drug for off-label purposes, they can prescribe whatever they want. Thus, to expand the use of their products, the companies simply construe marketing information as educational information.

What’s more, because in most states doctors are required to receive continuing medical education throughout their professional lives, most doctors earn the credits by attending meetings and lectures. In 2001, drug companies paid for over 60 percent of the costs for these events, an amount that has increased since then. To provide the education, the sponsoring drug company contracts with a private medical education and communication company, which in turn plans the meetings, prepares the teaching materials, and procures speakers. This conflict of interest was made clear in the pitch made by one of these communication companies to the sponsoring pharmaceutical company: “Medical education is a powerful tool that can deliver your message to key audiences, and get those audiences to take action that benefits your product.” Translation: hire us and we’ll get doctors to prescribe your drug. Research has shown that doctors prescribe more of the sponsors’ drugs after these meetings.

Another way companies “educate” doctors is to buy reprints of journal articles that reflect well on their drugs, then distribute those to doctors. Reprints are hugely profitable for the journals. An editor can often tell in advance which articles are likely to bring in big reprint fees, such as a large positive clinical trial of a new drug. For example, the New England Journal of Medicine sold 929,400 reprints of Merck’s VIGOR study, the notoriously misleading trial of Vioxx that Merck used as a major marketing tool. These reprints brought in between $697,000 and $836,000 for the NEJM. (The NEJM eventually repudiated the VIGOR study, but did not return the money.)

Next week: An example of drug sales gone amok

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.

Pharmaceutical ghost writers

Pharmaceutical companies pay professionals to write journal articles that are passed off as the work of academics. Here's how it works: 

Most clinical research on drugs is sponsored by the companies that make the drugs. Even though the research may be carried out by academic institutions, the sponsoring companies are involved in every detail of the research, including study design, data analysis, and decision about whether to publish. In this way, academic medical centers have become partners of the pharmaceutical industry, and, in a sense, academic researchers are little more than hired hands for the pharmaceutical companies. Loss of independence by faculty researchers is made up for by lucrative financial arrangements with drug company sponsors. For example, in 1998, the head of the Department of Psychiatry at Brown University Medical School made over $500,000 in consulting fees provided by a pharmaceutical company.

When it comes time to write up the results of the research, “publication planning” agencies step in. These are companies--more than 250 of them--who work with pharmaceutical companies to manage the marketing campaign of the soon-to-be new drug. In the words of one planning agency, they determine how to “connect data to key messages to support product positioning." To do this, they look at a range of marketing issues, such as how the new drug differs from other drugs on the market, which practitioners need to be reached, and what sort of scientific journals should be targeted. The articles are then written not by the academic researcher but by professional ghost writers who work for the publication planning agencies.

Here’s how the article gets written: The publication planning agency and drug company marketers first agree on a title for the article, then decide on a potential “author” for it—usually an academic physician with a reputation as a leader. The potential author agrees on a fee ($1000 to $2,500 per article). The ghostwriter writes the article (or an extended outline), submits it to the “author,” who then asks for changes or approves it. The article is then submitted to a journal, where, if all goes well it is published under the “author’s” name.

The chief editor for the British journal, Lancet, lamented, "journals have devolved into information laundering operations for the pharmaceutical industry." 

Next week: Passing off marketing as education

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.

Expanding the market for me-too drugs

In an effort to make the most money from “me-too” drugs, drug companies look for target markets with the following characteristics, as outlined by Dr. Marcia Angell, former editor of the New England Journal of Medicine:  

1.      Be large enough to accommodate a number of drugs that are all competing for the same market. Such markets generally consist of people with health conditions that are both common and chronic, such as arthritis, hay fever, or depression—ailments that don’t go away. This type of market is far more lucrative than those that target transient conditions, such as acute infections, or lethal conditions, which kill the customer.

2.      Consist of customers who can afford the drugs. As Dr. Angell says, “the pharmaceutical industry is supremely uninterested in finding drugs to treat tropical diseases, like malaria or sleeping sickness or schistosomiasis. Although these disease are widespread, they are not important to the industry, since those who suffer from them are in countries too poor to buy drugs.”

3.      Be highly elastic, so it can expand. The most common way to expand the market is to create new medical conditions, such as “pre-hypertension” (BP between 120 over 80 and 140 over 90), or to lower the cutoff point for high cholesterol from 280 milligrams per deciliter to 200. By lowering the thresholds for illness, you increase the sales of drugs.

Companies can also expand their markets by promoting “diseases” to fit their drugs. For example, at one time, “acid reflux disease” was called “heartburn,” and you dealt with it by drinking a glass of milk or an over-the-counter antacid. Now it is marketed as a serious esophageal disease, which it usually is not. Other examples are premenstrual tension, now called “premenstrual dysphoric disorder;” or impotence, now called “erectile dysfunction.” 

There’s also “social anxiety disorder,” a disease created for the drug Paxil. (Because few psychiatric disorders have objective criteria for diagnoses, they are easier to expand than most physical illnesses.) As Paxil’s product director told Advertising Age, “Every marketer’s dream is to find an unidentified or unknown market and develop it. That’s what we were able to do with social anxiety disorder.” Not feeling anxious? Just tune into a commercial for Paxil, which showed the World Trade Center towers collapsing.

Recently, a company expanded their market for Vyvanse, a type of amphetamine used to treat attention deficit hyperactive disorder. It's now promoted as a treatment for binge eating. Plenty of customers there.

Next week: Passing off ghost-written articles as the work of academics

For an introduction to this blog, see I Just Say No; for a list of blog topics, click the Topics tab.