The PPI battles
For those who are not jiggy with the lingo, PPI stands for proton pump inhibitor. This drug class includes Prilosec, Prevacid, Aciphex and Nexium (apologies to foreign readers – these are the US trade names). Since their introduction in the 80s they have made large amounts of money for their respective drug companies. That will probably change very soon. Heartburn Drug Battle Likely
Cracks appeared yesterday in a pillar of drug industry profits with twin announcements that users of a huge-selling heartburn drug will soon have alternatives that will be cheaper and easier to buy. As a result, the biggest fight ever seen between managed-care companies and drug makers could soon begin.
In the first announcement, Novartis said it would soon start selling omeprazole, the generic version of Prilosec, even though a court has yet to approve the sale. The aggressive move could open Novartis to huge damages if a judge eventually ruled that its generic version infringed patents owned by AstraZeneca, which sells Prilosec. But it also means that consumers will soon save a bundle on the medicine. Prilosec currently sells for $116 for a month’s supply on Drugstore.com. A lone generic version introduced in December sells for $100; with more generic entries, analysts said the price could drop to $11.
Then Procter & Gamble said yesterday that it would begin selling an over-the-counter version of Prilosec on Sept. 15, priced about 70 cents a pill, or $22 or so for a month’s supply.
The two announcements would not be so important if Americans collectively did not eat so much late-night pizza. But the obesity epidemic and the eating habits that have contributed to it have led to an explosion in heartburn in the United States.
Prilosec and its cousins Nexium, Prevacid, Protonix and Aciphex ? collectively known as proton-pump inhibitors, or P.P.I.’s ? are now the biggest-selling drugs in the world, with $13 billion in United States sales last year, according to NDC Health, a health information company. Prilosec’s $4.6 billion in sales last year brought at least twice the profit generated by every McDonald’s, Wendy’s, KFC, Taco Bell and Pizza Hut combined.
But every P.P.I. works almost identically, and there is little evidence that one is any better than another. So when prices of both generic and over-the-counter versions of Prilosec plunge, managed-care companies will try to persuade patients taking other pills to switch. Some will probably stop paying for other brands altogether.
For all P.P.I’s, the average monthly out-of-pocket payment for people with insurance is already more than $30 ? which exceeds the expected price of a month’s supply of over-the-counter Prilosec. And that average payment will probably increase.
Drug makers, on the other hand, will use their considerable marketing muscle to persuade doctors and patients that they should remain loyal to brand-name prescription pills no matter the price. In similar previous battles, drug makers have generally come out on top.
Several key points here. First, the drugs are not very expensive to make – otherwise the OTC price would be much higher. Second, we will see a marketing battle over PPIs, not an efficacy battle. The NY Times article correctly states that the drugs all work the same. One does need to adjust the dose to achieve equivalence, but omeprazole (Prilosec) works very well.
I expect this rant will receive many testimonials both pro and con. To understand the passion this subject develops check out this December 2002 rant and examine the number of comments – Generic omeprazole . The NY Times predicts that physicians will go generic in this situation.
“A P.P.I. is a P.P.I.; they’re interchangeable,” he said. Dr. Seidman predicted that generic and over-the-counter versions of Prilosec would greatly reduce the money his patients spend on other P.P.I. brands.
Dr. Mark A. Fendrick, editor of The American Journal of Managed Care, said other companies would follow WellPoint’s lead. “This is going to be a real test of how well managed-care companies can fight against the marketing power of the branded pharmaceutical industry,” Dr. Fendrick said.
I like these announcements. OTC Prilosec and generic omeprazole (with competition) will save patients and insurance companies money. The pharmaceutical companies deserve an appropriate return on their investment. They have received excessive return thus far and hopefully these announcements will bring those returns back in line for this drug class.
Most coronary artery disease patients have at least one risk factor
Common wisdom has stated that many patients with coronary artery disease have no known risk factors. The advocates of that position then argue against aggressive cardiac prevention. I do not know from where this “wisdom” comes, but data in today’s JAMA suggest that wisdom incorrect. Most Heart Disease Attributable to Common Risk Factors
Contrary to conventional wisdom, traditional cardiac risk factors are present in the majority of patients with coronary heart disease (CHD), according to the findings of two studies in the Journal of the American Medical Association for August 20th.
It is commonly believed that more than half of CHD patients lack any of the four major conventional risk factors–cigarette smoking, diabetes, hyperlipidemia and hypertension. This belief is “pretty wide-spread,” co-investigator Dr. Alan R. Dyer told Reuters Health.
“What it’s led to is a constant effort to find risk factors that explain CHD risk,” he added. “We found that most people are exposed to major risk factors, suggesting that perhaps we should spend more time trying to control those rather than search for novel risk factors.”
In one study, Dr. Eric J. Topol, of the Cleveland Clinic Foundation in Ohio, and colleagues analyzed data from 14 international randomized clinical trials of CHD. Included in the trials were more than 122,000 patients with ST-elevation myocardial infarction, unstable angina/non-ST-elevation myocardial infarction, and subjects who underwent percutaneous coronary interventions.
Between 85% and 90% of patients with premature CHD had at least one conventional risk factor. Only when age was above 75 years in women or 65 years in men did more than 20% of subjects lack any of the four major risk factors. When family history of CHD and obesity were factored in, only 8.5% of women and 10.7% of men had no risk factors.
Men 50 years or older and women 55 years or older “who have any of these risk factors are within the zone where the 10-year risk is clearly greater than 10%,” Dr. Topol told Reuters Health. He recommends that when patients present with any of these risk factors, clinicians should consider a thorough evaluation, including exercise-stress testing and checking serum levels of C-reactive protein.
In another study, a team led by Dr. Philip Greenland, at the Feinberg School of Medicine in Chicago, examined three prospective cohort studies for which follow-up lasted 21 to 30 years.
For the nearly 21,000 patients with fatal CHD, exposure to at least one clinically elevated major risk factor ranged from 87% to 100%. When cut-offs were established for higher-than-favorable levels (cholesterol at least 200 mg/dL, blood pressure > 120/80), 96% to 100% of all age-sex groups with fatal CHD had prior exposure to a risk factor. These findings were consistent across cohorts and range of baseline ages under 60.
Even among subjects with treated hypertension or treated hyperlipidemia, prevalence of fatal CHD was elevated, Dr. Dyer, of the Feinberg Medical School and co-author of Dr. Greenland’s study, told Reuters Health. “Even if blood pressure or cholesterol levels are reduced to typical cut-points, the reduction in risk is less than you might expect.”
Dr. Topol agreed, adding, “Treatment of hypertension or hypercholesterolemia is only a palliative modulating force, it doesn’t negate the intrinsic problem.”
According to Drs. John G. Canto and Ami E. Iskandrian from the University of Alabama at Birmingham, these reports “may have enormous public health implications for targeting a large segment of the population at risk of developing CHD,” especially since rates of exposure were probably underestimated. In an editorial, they recommend that aspirin, statins, and ACE-inhibitors be considered for all patients with atherosclerosis and diabetes.
JAMA 2003;290:891-904, 947-949.
These articles are very important. I agree with my UAB colleagues (disclaimer – I do research with Dr. Canto and we are co-authors on several papers – we also are working currently on a major grant which addresses risk factor reduction in post-MI patients).
