Statins

U.K. aims to put 1.5M on preventive statins

Tracy Staton — Wed, 28 May 2008 10:03:15 -0400

New U.K. guidelines for heart-attack prevention could be a major windfall for statin-makers. The National Institute for Health and Clinical Excellence wants docs to search their patient rolls for people over 40 at risk of heart attack and stroke--and put them all on the cholesterol-fighting meds. According to agency estimates, 1.5 million more people would thus be added to the millions who already take statins, preventing 15,000 heart attacks, strokes, and angina cases per year.

The caveat: All the patients turned up during this hunt for heart risk will be put on simvastatin, which of course is a generic form of Zocor. So the intitiative is not likely to aid brand-name drugmakers. But if the idea spreads, the likes of Lipitor and Crestor may end up sharing the wealth.

- see the story in the Telegraph
- read the BBC coverage

Make generic-switching bonuses illegal?

Mon, 05 May 2008 06:59:55 -0400

Should insurers be allowed to reward docs who switch patients to generics? That debate is going public in Colorado, where legislators have proposed a bill that would prohibit the practice. On the "pro" side: Sen. Paula Sandoval, who sponsored the bill; she says docs should be thinking about patients, not money. Also on the pro side: Pfizer.

The AARP, Kaiser Permanente, and the Colorado Association of Health Plans are on the "con" side in this debate. Interestingly, Kaiser's opposition doesn't stem from support of the payments. The insurer is decrying a lack of reciprocal bans on Pfizer and other drugmakers, which leaves pharma free to incentivize docs--with gifts, lunches, and so on--to buy more expensive meds.

You'll recall that last year, a Blue Cross HMO offered to pay $100 each time a doctor switched a patient off an expensive brand-name cholesterol med--such as Pfizer's Lipitor--to a cheaper generic. The 90-day program saved Blue Care Network $5 million, a company spokeswoman said. But the plan drew sharp criticism; some charged it put money before patients' interests.

- read the Associated Press story
- check out the Denver Post article

Woodcock: FDA wary of Vytorin debate

Wed, 09 Apr 2008 06:59:56 -0400

Expect the FDA to stay out of the Vytorin fray, at least for now. So Janet Woodcock (photo), CDER chief, told FDAWeb in an interview (recounted, in turn, by Pharmalot). The agency is afraid of seeming "defensive" if it weighs in now. But Woodcock did make clear that FDA still considers lowering "bad" cholesterol--which Vytorin did quite well in the Enhance study--to be a valid surrogate for heart-disease prevention.

Scientific nitpicking about LDL is misleading people, Woodcock said: "[T]here is some little point that the scientists are arguing about, and then the media get on it, and they start throwing the baby out with the bathwater," she said. "...[but if] people think we're just being defensive, we wouldn't make a difference in this environment."

Meanwhile, new data is in on the expected drop-off in Vytorin and Zetia scrips. A Deutsche Bank analyst surveyed primary care docs and found that 75 percent expect usage of both drugs will drop in their practices. The analyst now predicts that market share for Vytorin will drop to 9 percent from 16 percent. Zetia, one of the drugs in the Vytorin combo, will see its share drop to 6 percent from 9.5 percent, the analyst concluded.

Some of that drop-off will be in new scrips, some from patients switching. In an investor note, the analyst predicted "increased utilization of other statins, especially [Pfizer's] Crestor."

- see the Woodcock interview excerpt at Pharmalot
- check out the scrip numbers
- see Pharmalot's analysis of Deutsche Bank's predictions

Related Articles:
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FDA chief: Woodcock is a 'change agent'
UnitedHealth stands by Vytorin
Insurers, PBMs mull Vytorin data.
Congress: Merck, Schering-Plough sat on bad news
ACC panel unleashes Vytorin whirlwind

FDA shoots down Mevacor OTC

Mon, 28 Jan 2008 06:59:56 -0500

It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. About a month after an advisory panel said "nay" to the idea, the FDA sent Merck a not approvable letter. It's the third time the agency has denied Merck's request to sell Mevacor without a prescription.

This time, there was an added wrinkle: GlaxoSmithKline had inked a deal with Merck for the over-the-counter rights to Mevacor in the U.S. So Merck was asking the FDA for an OK on GSK's behalf. The panel's chief concern: that even Merck's own patient survey showed some who shouldn't be taking statins would choose to do so.

Merck's OTC group is now "evaluating the conditions outlined in the agency's response" to see where to tack next. The FDA asked for a revised label--and, most importantly, for additional data. We'll see what Merck can pull out of its hat.

- see the release
- read the report from CNN Money
- here's a PharmaTimes article

Related Articles:
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Merck faces fierce debate on OTC statin. Report
GSK buys OTC rights to Merck statin. Report
Switching to generic statins not so healthy. Report

Insurers pay docs for generic-switching

Fri, 25 Jan 2008 06:59:54 -0500

Maybe the folks probing drug company payments to docs should expand their field a bit. Now, health plans are drawing scrutiny for paying physicians to prescribe cheaper generics rather than brand-name drugs. Some are even greasing docs' palms each time they switch patients off branded meds.

Patient advocates and legislators are fired up about it, worried that decisions based at least in part on financial incentives are inherently suspect. One would think that pharma could get fired up, too. After all, drug makers already face enough generic pressure.

According to The Wall Street Journal, the incentive plan that's drawn the most fire is one started last year by Blue Care Network, part of Blue Cross Blue Shield of Michigan. Primary care docs got $100 for each plan member who switched to a generic statin. Helpfully, the HMO mailed docs a list of patients who were on the brand-name meds Lipitor (Pfizer) and Lescol (Novartis). The HMO spent $2 million on the three-month program--saving $5 million in drug costs in the process. Along the way, the American Medical Association advised docs that such payments could violate antikickback statutes. Now, a legislator in Massachusetts has introduced a bill to "keep [the practice] from spreading."

- read the Wall Street Journal article

Related Articles:
Switching to generic statins not so healthy. Report
The specter of generic competition grows. Report
Pharma faces "tidal wave" of generics. Report

Heart docs back Vytorin

Wed, 16 Jan 2008 06:59:55 -0500

Day three of chatter about Vytorin's poor performance in the ENHANCE study, and the furor seems to be increasing. On one side: The notorious Dr. Steve Nissen--and various other experts and doctors--who say Vytorin either shouldn't be used at all, or might be useful after other statins have failed. On the other: The American College of Cardiology.

The elite group of heart specialists says that "major clinical decisions" shouldn't be made based on the new study data. "Conclusions should not be made until the three large clinical outcome trials are presented within the next two or three years," the ACC said in a statement. "Zetia remain[s] a reasonable option" for certain patients, the group added. Wall Street analysts called the ACC statement "a major win for Schering-Plough and Merck."

Meanwhile, other experts say that the outcomes studies aren't likely to show much advantage for Vytorin. And amid questions about why Vytorin ever got approved in the first place, the FDA says it's evaluating the data, including--Time magazine says--ads that claim the drug could overcome high cholesterol whether caused by diet or genetics. The New York Times weighed in with an editorial saying that unless and until the outcomes studies show big benefit for Vytorin, the drug "should be used sparingly." Stay tuned for more expert and quasi-expert judgment. We're sure plenty of it will continue to fly.

- here's the statement from the ACC
- see the report in Time magazine
- read the editorial from The New York Times
- see this item from the Wall Street Journal's Health Blog

Related Articles:
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Merck, Schering's Vytorin fails trial. Report
Merck, Schering left trial chief out. Report
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Merck, Schering backpedal on Vytorin. Report

Merck, Schering's Vytorin fails trial

Mon, 14 Jan 2008 06:59:56 -0500

The gig is up, the news is out. Merck and Schering-Plough announced the results of its big ENHANCE trial this morning. And, as observers had begun to suspect, the study showed that, when it comes to arterial thickness, there was no significant difference between treatment with generic simvastatin (Zocor) and Vytorin, which combines Zocor and Zetia (ezetimibe).

The study did show a big advantage in cholesterol-lowering with the combo treatment, Vytorin. Patients saw their "bad" cholesterol drop by 58 percent with Vytorin versus 41 percent with Zocor alone. But other studies haven't shown a difference in patient outcomes, such as fewer heart attacks or strokes.

As you know, Merck and Schering embarked on this study hoping that Vytorin could trounce Zocor, and therefore elbow aside not only Zocor's generic competitors but other statins, too. But after the data came in, the companies delayed its release, and even made a feint toward changing the trial's primary endpoint. Critics denounced that idea, and the streets were buzzing with speculation about the trial results. (It didn't help that the companies were accused of withholding damaging data from other Vytorin studies.) Apparently, Merck and Schering decided that the truth, while none too impressive, was better than the speculation.

- see the release from Merck
- read a brief story from Dow Jones
- read some cardiologists' speculation in the Wall Street Journal Health Blog

Related Articles:
Merck, Schering left trial chief out. Report
Schering CEO defends Vytorin decisions. Report
Merck, Schering backpedal on Vytorin. Report

SPOTLIGHT: Study: Diabetics should take statins

Fri, 11 Jan 2008 06:59:52 -0500

For the second time this week, statins are being trumpeted for a new population. This time, it's diabetics who should be taking the cholesterol-lowering drugs; researchers found that deaths among diabetics fell by 9 percent with each statin-spawned step reduction in cholesterol. Report

Study: Statins cut cancer by 25%

Wed, 09 Jan 2008 06:59:55 -0500

It's potential manna from heaven for statin makers: A new study shows the drugs may prevent cancer. Real FDA-sanctioned marketing is years of research away, but we expect a flurry of journal article reprints in doctors' mailboxes in the meantime. Just think of the patients who are, for whatever reason, iffy about going on a statin. One mention of the Big C-word, and they might zip over to the pharmacy posthaste.

This new study, published in the Journal of the National Cancer Institute, looked at two groups of veterans: those on blood-pressure meds and those on statins. A little over 9 percent of the statin patients developed cancer; 13 percent of the others did. What's more, the higher the statin dose, the lower the incidence of cancer.

The study has its limits, though. Researchers couldn't adjust for smoking or alcohol use, for instance. And it's a meta-analysis, useful more for pointing the way to rigorous trials than for, say, expanding the approved uses of a drug.

- here's the summary from JNCI
- check out this Pharmalot item

Related Articles:
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Schering CEO defends Vytorin decisions

Fri, 04 Jan 2008 06:59:58 -0500

Talk about the hot seat. At a Morgan Stanely pharma conference yesterday, Schering-Plough CEO Fred Hassan (photo) was quizzed and re-quizzed by investors about the Vytorin-Zetia controversy. (In case you missed it, Schering and its partner Merck drew fire last month for allegedly holding back data on the cholesterol fighters, some from studies that indicate Zetia might cause liver problems, plus an entire trial pitting Zetia-plus-Zocor against Zocor alone.)

Hassan pooh-poohed the buzzing about the latter trial, saying that the 720 patients involved had very high cholesterol because of genetics, so that data shouldn't affect the use of Vytorin (which combines Zetia and Zocor) in regular patients. But investors at the meeting weren't satisfied. Pressing Hassan on the science of statins, they asked whether Vytorin--which is very good at lowering cholesterol--also carries all the benefits of other statins such as Lipitor. Hassan had no direct answer.

As for the liver questions, Schering's R&D chief Thomas Koestler acknowledged that some Zetia patients had abnormal results on liver-function tests, but they generally showed no symptoms. Serious problems, he said, "are extremely rare."

- read the article from the Wall Street Journal Health Blog

Related Articles:
Merck, Schering backpedal on Vytorin. Report
A new 'religion' at Schering-Plough. Report