Gilead Sciences will acquire CV Therapeutics, makers of ranolazine (Ranexa) and regadenoson (Lexiscan). The announcement comes on the heels of Astella’s hostile attempt to acquire CV Therapeutics, as previously reported by CardioBrief.
Gilead is buying CV Therapeutics for approximately $1.4 billion, at a cost of $20 per share. Astellas previous offer was for $16.
Click here to read the Gilead press release…
A new diagnostic test may represent a substantial advance in the otherwise difficult to diagnose arrhythmogenic right ventricular cardiomyopathy (ARVC), according to a new study published in the New England Journal of Medicine. ARVC may be caused by mutations in desmosomal proteins; the new study found lower levels of the desmosomal protein plakoglobin on immunochemistry of autopsy or biopsy-obtained myocardium.
Although some people think statins should be put in the water, others have voiced caution about extrapolating the benefits of statins to an ever-wider population. A new study, presented today at the American Heart Associations’s Nutrition, Physical Activity and Metabolism Conference in Palm Harbor, Florida, provides some evidence for being cautious, and may well engender some controversy.
Beatrice Golomb (UC San Diego) and colleagues randomized patients to pravastatin or simvastatin for 6 months and measured energy and interest in activity before and after treatment. Both statins resulted in unfavorable changes, but the resuls were significant only with simvastatin, a more potent and lipophilic statin.
Golomb sent CardioBrief a detailed discussion of her study:
Click here to read Golomb’s discussion and the AHA press release…
Here comes da judge! Despite charges that he has a conflict of interest, the judge who dismissed the lawsuits against Medtronic in the Sprint Fidelis cases will not step down, according to an AP report by Matthew Perrone and a Star Tribune story by Janet Moore. On Monday the judge ruled that he was not required to recuse himself simply becasue his son is a partner in a law firm that does work for Medtronic. Here is CardioBrief‘s earlier report on this story.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee and Circulatory System Devices Panel are each set to meet next week, when they will evaluate the drugs rivaroxaban and dronedarone and the TherOx Aqueous Oxygen System for infarct size reduction.
Click here for more details about the advisory panel meetings…
The American Heart Association’s chief science officer, Rose Marie Robertson, spoke with CardioBrief to clarify and discuss the AHA’s position regarding the SHAPE-inspired legislation in Texas (see our previous story). Robertson confirmed that the AHA has indeed declined to endorse the proposed bill. Although Robertson would not rule out a legislative approach in the future, she did observe that it is “a very blunt instrument.”
Click here to continue reading…
The FDA has posted a transcript of the controversial February 3 meeting of the Cardiovascular and Renal Advisory Committee, along with minutes and revised briefing documents.
Here is a chronology of coverage of this hearing by CardioBrief and others.
You can download the transcript here.
You can download the minutes here.
You can access the FDA’s revised briefing document and errata, as well as Lilly’s briefing document, here.
The American Heart Association has denied that it is supporting the SHAPE-influenced Texas legislation that would mandate insurance company reimbursement for heart attack screening.
Earlier today, as reported in CardioBrief, SHAPE issued a press release in which it quoted Dr. Morteza Naghavi, founder of SHAPE and Chairman of the SHAPE Task Force:
“We are also pleased to know that the American Heart Association has elected to support the bill as well. This is truly groundbreaking landmark legislation, much like the legislation for mammography,”
An AHA spokesperson told CardioBrief that the AHA has not altered its position, and that it can not support the Texas legislation without firmer scientific support. The SHAPE spokesperson told CardioBrief that the legislation had been endorsed by Joel Romo, the AHA’s regional vice-president for advocacy. But when we spoke with Romo this afternoon, he denied giving the endorsement. He told CardioBrief that he had told the Texas legislators that “I don’t know if we are there yet” and that without better scientific evidence the AHA would be unable “to put a card in favor” of the legislation (which is apparently Texas political lingo for endorsing a bill).
Stay tuned to CardioBrief for more developments.
Women enrolled in the Nurses Health Study with severe depression were more than twice as likely as other women to experience sudden cardiac death or fatal coronary disease, according to a new study published online today in the Journal of the American College of Cardiology. The authors were surprised to find that antidepressant use was even more strongly tied to cardiac events, raising the possibility of a proarrhythmic effect of antiarrhythmic drugs, though they believe that the proven benefits of antiarrhythmics still outweigh any possible risks.
An accompanying editorial by Narayan and Stein agrees, concluding that “if antidepressant use merely indicates severe depression, these results could suggest that depression should actually be treated more aggressively. Thus, at the present time, the absence of proof that antidepressants might cause cardiac events is more relevant than conclusive proof that this effect is absent. Nevertheless, these findings are sufficiently sobering to warrant heightened clinical surveillance and to initiate studies to definitively address this relationship.”
Click here to read the ACC press release…
A new meta-analysis has found a strong association for both primary and secondary coronary events and anger and hostility. The harmful effects of anger and hostility were stronger in men, according to the study published online today in the Journal of the American College of Cardiology. Johan Donellet, in an accompanying editorial, makes the case for overcoming skepticism that “psychological factors do matter in CHD.” Further, “although we might be far from having all of the answers, the risk associated with psychological factors is similar to that of other clinical risk indicators.”
Click here to read the ACC press release…
Using data from NHANES and extrapolating from JUPITER, Eric Michos and Roger Blumenthal have calculated that 6.5 million additional adults could be candidates for statin therapy. The paper appears online in the Journal of the American College of Cardiology. By treating people with elevated hsCRP who are otherwise considered low risk, “this strategy could potentially prevent 260,000 events at 5 years.”
The Texas legislature is about to reconsider a controversial bill that would mandate insurance company reimbursement for heart attack screening tests. The bill was first proposed two years ago, with strong support from the Society for Heart Attack Prevention and Eradication (SHAPE).
The proposed bill represents an effort to provide legislative muscle to the equally controversial SHAPE guidelines, published in 2006 in a supplement to the American Journal of Cardiology sponsored by Pfizer. Despite the presence of many well-respected senior cardiologists on the list of authors, including PK Shah, Pamela Douglas, and many others, the guidelines were roundly criticized, as they did not represent the findings of a government agency or one of the major cardiology organizations. (You can read the story in Heartwire.)
According to the SHAPE press release (see below), the AHA has now endorsed the Texas bill. CardioBrief has asked the AHA to clarify its position.
Click here to read the SHAPE press release…
The US Department of Justice is investigating Medtronic’s marketing practices and reimbursement advice for its surgical ablation devices. You can find the following text buried on page 52 of Medtronic’s Form 10-Q quarterly report on file with the SEC:
On February 9, 2009, the Company received letter notice that the United States Department of Justice in the Southern District of Texas is investigating marketing practices, reimbursement advice of the Company and appropriateness of therapy delivery relating to the Company’s cardiac surgical ablation devices. The Company is in the process of responding to the requests of the government, and will comply as required with the investigation.
The news was first reported in a Bloomberg news story.
The association between influenza infection and cardiovascular events has been noted for many years, and flu vaccines have become an accepted part of clinical practice for high risk patients. However, it has not been known whether treating flu can reduce subsequent cardiovascular events. Now, a new retrospective study of 37,000 cardiovascular patients with flu, published online in Circulation: Cardiovascular Quality and Outcomes, has found that treatment with oseltamivir significantly reduced the rate of recurrent cardiovascular events. The authors conclude:
Click to continue reading…
Generic simvastatin is cost effective in a much wider population than indicated in current guidelines, according to a new cost-effectiveness study published online in Circulation: Cardiovascular Quality and Outcomes. The Heart Protection Study Collaborative Group combined data from the 20,000 patient HPS study with cost data from the US to estimate the effectiveness of simvastatin for people at different levels of risk. They concluded that generic simvastatin “appears to be very cost-effective for individuals (independent of their age) with annual risks of major coronary and other vascular events well below the levels currently required by national guidelines. As a consequence, existing guidelines should be modified to extend statin treatment to a much wider population.”
Leading British cardiologist Professor Philip Poole-Wilson died yesterday on his way to work, according to published reports in Heartwire and on the European Society of Cardiology website. Poole-Wilson was a major figure in British, European, and international cardiology circles. Click here to continue reading…
Microvolt T-wave alternans (MTWA) testing has been proposed as a relatively easy method to identify patients who are otherwise indicated for ICD implantation but who may safely avoid or postpone receiving the device. Another use is to help convince patients who may need an ICD that they are in fact at high risk, or at least not at low risk, for sudden cardiac death.
There’s been a lot of debate and discussion about the clinical value of MTWA, but it’s safe to say that it has struggled to achieve clinical acceptance.
Click here to continue reading…
Following our earlier post in which he set the record straight that his $2.75 million salary places him at the top of the heap of New York City interventional cardiologists, Samin Sharma spoke with Mike Gibson, founder and editor of our sister site, ClinicalTrialResults.Org. You can watch the fascinating video and learn some of the secrets behind performing 1,500 cases a year. One tip: be prepared to wake up at 4:30 AM without the help of an alarm clock. In addition, Sharma’s caseload appears even more impressive when you learn that he’s only a part-time interventional cardiologist, working just three days a week. He spends the other two days a week helping Valentin Fuster run the Cardiovascular Institute at Mt. Sinai.
PPI use can diminish the beneficial effects of clopidogrel, according to a retrospective study from the VA of more than 8,000 ACS patients published in JAMA. The results are in accord with prior mechanistic studies, and suggest the need for further prospective studies. For now, the authors write, “the results of this study may suggest that PPIs should be used for patients with a clear indication for the medication, rather than routine prophylactic prescription.”
Click here to read the JAMA press release…
Both the New York Times
and the Indianapolis Star
are reporting that the approval of prasugrel may be delayed due to the congressional investigations into the “mistakes” the FDA admits having made in disinviting Sanjay Kaul from the advisory committee hearing last month. (CardioBrief
was the first to report on this event. You can follow the complete chronology of events here
.) The articles appear to rely heavily on a Cowen & Company analyst’s report, summarized in Barron’s
, which also lowers its estimates of prasugrel’s eventual sales.
I have no way of knowing whether the Cowen analyst is right, but even the suggestion that prasugrel might be delayed raises some very important issues. Most notably: if prasugrel is delayed, who is to blame?
I suppose some people might blame CardioBrief, and other journalists from the New York Times to Heartwire and the blogosphere, for making an issue about Kaul’s absence in the first place. But it seems to me that the real blame lies with the FDA, and partly with Lilly (and perhaps others as well), who somehow thought that Kaul’s presence on the advisory committee represented a threat to prasugrel that somehow needed to be neutralized.
Let’s try a thought experiment: imagine for a moment that Kaul had not been disinvited and that he had participated in the committee meeting.
Risk-adjusted outcomes of PCI have been published in New York for more than a decade, and since 2003 in Massachusetts. Two interventional cardiologists at the Brigham and Women’s hospital in Boston review the unintended consequences that may be caused by public reporting in the latest edition of JACC. Their analysis, they write, “raises concern over whether overall mortality is a reliable guide to quality. As practicing interventional cardiologists, we are concerned that we occasionally consider the impact of potential adverse events on our hospital’s outcomes when evaluating the risks and benefits of a procedure for a particularly ill patient. However well-intentioned the practice of public reporting may be, the consequences appear to have had the opposite effect.”
In an accompanying comment, Duke’s Rob Califf and Eric Peterson note that public reporting of outcomes has a longer history than many believe:
Click here to read more about Califf’s and Peterson’s commentary…
The FDA has approved the Navistar RMT Thermocool Catheter from Biosense Webster, a Johnson & Johnson company. The catheter is used with Stereotaxis’s Niobe Magnetic Navigation System, which helps steer a catheter remotely and guide ablation to targeted areas that require treatment.
Click here to read press releases from Biosense Webster and Stereotaxis…
In 2004 Medicare mandated the creation of a national ICD registry, which has been run since then by the ACC and HRS. Now, New York Times reporter Barry Meier, who has been instrumental in bringing to light ICD problems in the past, notes in a February 26 story that the ICD registry is languishing for lack of financial support from industry. Due to industry neglect, the registry has failed to identify new problems, such as the recent study showing a high rate of problems with the Sprint Fidelis leads.
Meier quotes Northwestern University’s Alan Kadish, who said “he did not think that manufacturers believed that they would ‘be fulfilling their fiduciary obligations to shareholders by funding’ studies that compare the effectiveness of their devices to those of competitors.” Now hospitals pay for their participation in the registry, but Meier writes:
Click here to continue reading…
The controversy surrounding the FDA’s cardiorenal advisory committee meeting, and in particular the “disinvitation” of Sanjay Kaul from the meeting, has prompted two separate congressional investigations. (Click here to see CardioBrief’s chronology of events.)
As reported by Susan Heavey in Reuters, Rep. Bart Stupak, the chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations is writing letters of inquiry to the FDA and to Lilly.
Separately, Rep. Maurice Hinchey, a member of the House Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies, which allocates the FDA’s budget, sent a letter to the FDA’s Janet Woodcock, in which he asks:
“How can we trust the FDA if a drug maker like Eli Lilly can get a potential agency advisor that it doesn’t like disqualified from submitting an opinion?”
Click here to view Rep. Hinchey’s press release and letter to Janet Woodcock.
Astellas Pharma announced today that it was launching a hostile takeover for CV Therapeutics, the company that manufactures ranolazine (Ranexa) and regadenoson (Lexiscan).
As we reported back in January, CV Therapeutics previously rejected a friendly bid at the same price from Astellas. Astellas already markets regadenoson in the US.
Astellas offered an explanation for the hostile takeover: “While we continue to prefer to reach a negotiated agreement with CV Therapeutics’ Board, their refusal to engage with us regarding our proposal has left us with no alternative but to take our offer directly to CV Therapeutics’ stockholders. We believe our offer provides CV Therapeutics’ stockholders with immediate cash value that exceeds what the company could reasonably expect to deliver on it own, particularly given current uncertain market conditions and execution risks inherent in CV Therapeutics’ standalone strategy.”
Click here to read the Astellas press release…