Archive for April, 2010

Heralded Heart Drug not as good as Generics

April 30th, 2010 | No Comments | Source: JACC, LA Times

Multaq, an expensive new drug for the treatment of atrial fibrillation, is only half as effective as amiodarone, its generic congener, and it has a similar side-effect profile according to Sanjay Kaul and colleagues at Cedars-Sinai Medical Center.

heartbreakingnews 300x299 Heralded Heart Drug not as good as GenericsAs a result Multaq should be reserved for patients in whom amiodarone is ineffective or associated with intolerable side-effects, the scientists concluded in an op-ed piece in the Journal of the American College of Cardiology.

Their conclusion is based on a review of 3 clinical trials (summarized below). It represents a huge setback for Multaq, which was at one time touted to be a potential blockbuster with annual sales in the billions.

Multaq “has only modest efficacy and no clear-cut safety advantage,” Kaul told the LA Times. The drug costs $9 per day, whereas amiodarone costs just a few cents. “Why would you want to use an expensive, ineffective alternative?”

Atrial fibrillation (AFib) affects 2.3 million Americans and causes about 71,000 deaths per year.

Afib is characterized by chaotic electrical and muscular activity in the upper chambers of the heart. The condition can predispose patients to strokes and can cause fatigue, dizziness, loss of consciousness or heart failure.

Amiodarone is highly effective in restoring normal cardiac rhythm in patients with Afib, but it is associated with frequent, potentially serious abnormalities of thyroid and lung function. Multaq was developed by Sanofi-Aventis as an alternative. 

The first trial showed that Multaq doubled the risk of death in patients with moderate- to high-risk for hospitalization and death from Afib.

The second showed that Multaq reduced hospitalizations from Afib, but there was no impact on mortality in lower risk patients.

The third revealed that Multaq was half as effective as amiodarone in preventing hospitalizations and deaths. There was no difference in the incidence of side-effects.

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Fruits, Veggies not much help against Cancer

April 29th, 2010 | No Comments | Source: BBC, J. National Cancer Institute

Twenty years ago the World Health Organization recommended that people should consume at least 5 portions of fruit and vegetables per day in order to prevent cancer and other chronic diseases. The advice has become gospel pretty much ever since.

TheBanana 300x199 Fruits, Veggies not much help against CancerUnfortunately, a recent study by Paolo Boffetta and colleagues at Mount Sinai School of Medicine does not substantiate the claim.

The scientists analyzed 500,000 subjects from 10 countries who were enrolled in the European Prospective Investigation into Cancer and Nutrition. They concluded that consuming an extra 2 portions of fruits and veggies per day could prevent at most 2.6% of cancers in men and 2.3% of cases in women, after accounting for lifestyle factors like smoking and exercise.

Even these modest gains could have been due to the fact that people who consumed more fruit and vegetables lived healthier lives in other respects, with the latter behaviors actually accounting for the gains.

The scientists found that vegetables, which tend to have more nutrients, were more beneficial than fruits, and that heavy drinkers and smokers appeared to gain the most from increased consumption of fruits and vegetables.

In an accompanying editorial, Harvard University nutrition expert Walter Willet said the study confirmed previous findings. “Any association of intake and fruits and vegetables with risk of cancer is weak at best,” he told the BBC.

Although the link between diet and cancer seems less certain, it is becoming increasingly clear that obesity is a major risk factor for cancer. Thus to the extent that fruits and vegetables are substituted in the diet for higher calorie foods, they could still drop cancer risk via this mechanism. 

The write-up appears in the Journal of the National Cancer Institute.

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Heart Risk found with Prostate Drug

April 27th, 2010 | No Comments | Source: AOLNews, NEJM

The results of a large study of Avodart for the prevention of prostate cancer have revealed an altogether unexpected finding: the drug increases the risk for heart failure. Avodart is typically used to treat urinary symptoms caused by an enlarged prostate gland. Heart failure had not been noted when men use it for this purpose.

whatamess 240x300 Heart Risk found with Prostate DrugThe study appears in the New England Journal of Medicine. It included 6,700 men that were between the ages of 50-75 and that had high PSA levels (PSA is a prostate cancer screening test) but no actual prostate cancer as revealed by a recent biopsy. Subjects were randomized to receive either Avodart or a placebo, and were re-biopsied after 4 years.

The new biopsies revealed cancer in 25% of subjects taking placebo, and 20% of those taking Avodart. Those findings match the cancer-preventing performance Merck’s Proscar, another urinary drug sold generically as finasteride, but the finasteride patients showed no signs of heart failure.

Heart failure developed in 30 men taking Avodart, compared with 16 men who received placebo.

Subset analyses showed that patients who developed heart failure tended to be taking other drugs which are known to precipitate heart failure, according to Glaxo spokesperson Sarah Alspach. The higher incidence of heart failure in the Avodart study “is unexpected and inconsistent” with previous research, she told AOLnews.

Last year, an expert panel recommended that men who are screened regularly for prostate cancer should consider taking Proscar or Avodart. It’s unclear whether the panel will revisit those recommendations in light of the new findings.

Both drugs cost about $3 per pill. To prevent one new case of cancer, 71 men would have to take Proscar for 7 years.

Prostate cancer is the most common non-skin cancer in US males. Roughly 192,000 new cases and 27,000 deaths were attributed to prostate cancer last year.

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Unpasteurized Milk Consumption in the US

April 26th, 2010 | No Comments | Source: Wall Street Journal

Approximately 3 million Americans consume unpasteurized milk each year. They believe “raw” milk contains enzymes, vitamins, beneficial bacteria and disease-fighting nutrients that are lost during pasteurization.

cow1 Unpasteurized Milk Consumption in the USThese beliefs persist despite the unanimous opinion of public health officials that the risks of unpasteurized milk outweigh any benefits, and that pasteurization—in which milk is heated to kill disease-causing bacteria—is by far the best way to assure milk is safe.

According to the CDC, there were 85 outbreaks of bacterial infections caused by raw milk consumption between 1998 and 2008. These outbreaks were associated with 1,614 reported cases of illness, 187 hospitalizations and 2 deaths. Deaths have also been caused by ingestion of fresh cheese made from raw milk, the CDC reports, especially the Queso Fresco cheeses which are favored by many Hispanic people.

Pregnant women, the elderly and children are particularly vulnerable to bacterial infections associated with raw milk, but healthy young adults can also be stricken.

cow2 Unpasteurized Milk Consumption in the USThe FDA bans interstate sales of unpasteurized milk for human consumption, but 28 states allow it to be sold, and others are considering doing so. These states impose their own laws regarding milk processing. Some require in addition that warning labels be affixed to milk containers.

In the aftermath of some recent outbreaks associated with unpasteurized milk, the FDA and CDC are ramping-up efforts to warn consumers about its dangers, and urging states to strengthen what regulatory controls they currently enforce. 

Pasteurization was widely adopted in the US around 1938. Before then, cow’s milk caused nearly 25% of all food- and water-borne disease outbreaks. “People don’t remember the bad old days,” Robert Tauxe, the CDC’s deputy director of food-borne and bacterial diseases division told the Wall Street Journal.

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Stopping Clinical Trials Early: The Downside

April 23rd, 2010 | No Comments | Source: BurrillReport, JAMA

Clinical trials are often stopped early when they show a convincing, apparent difference between an experimental intervention and either a placebo or an existing standard of care. The rationale for halting such trials is to let participants who were randomized to the placebo switch to the apparently effective intervention, and to help get the presumably improved therapy to market.

thisonewaseasy1 240x300 Stopping Clinical Trials Early: The DownsideHowever, a recent study by Dirk Bassler and colleagues at McMaster University suggests that halting trials early may lead to misleading overstatements concerning the apparent benefits of the intervention.

To reach this conclusion, Bassler’s team compared treatment effects from truncated randomized clinical trials (RCTs) with those observed in trials that addressed the same question but that were not halted early.

The analysis included 91 truncated RCTs and 424 matched, non-truncated RCTs. The results showed that the halted trials had reached exaggerated or misleading conclusions. Remarkably, 62% of the non-truncated RCTs showed no benefit at all for the intervention. Large differences between truncated and non-truncated trials were common when the truncated RCTs had fewer than 500 outcome events.

“Our research shows that in most cases early stopping of clinical trials resulted in misleading estimates of treatment effects,” Victor Montori, a Mayo Clinic endocrinologist and corresponding author of the study told BurrillReport.
 
The authors recommended that scientists truncate clinical trials only near the very end of a study and then only with “a very good reason.” Otherwise patients and physicians will be making treatment choices based on inaccurate information, or worse, opting for a treatment when another one may be more effective.

The study appears in the Journal of the American Medical Association.

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Millions Taking Unapproved Heart Pills

April 22nd, 2010 | No Comments | Source: NY Times

US physicians wrote 4.4 million prescriptions last year for nitroglycerin (TNG) tablets, those tiny pills in the tiny bottle that dissolve under the tongue and act in minutes to relieve chest pain associated with coronary artery disease.

thistimeitsthebigone 200x300 Millions Taking Unapproved Heart PillsTNG has direct vasdilatory effects on the coronary arteries. It also reduces blood pressure and cardiac “preload.” Patients take TNG when they first feel angina. They can take up to 3 if the first one doesn’t work. After that, they call 911.

TNG has been around forever, and it turns out that’s a problem. The pills predate the Food and Drug Administration itself, and were grandfathered-in as safe and above regulatory review in 1938 when the agency was formed.

The result is that 80% of the TNG prescribed in the US has never been tested for safety, potency or effectiveness. The only form of TNG that has received FDA approval is Nitrostat, which is made by Pfizer.

Amazingly, doctors just found this out last month. It’s possible that millions of patients may have been taking substandard or ineffective forms of the drug. Some of them may have been harmed by the oversight.

“If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective,” Harry Lever, a cardiologist at the Cleveland Clinic told the New York Times.

Late last month, the FDA warned the 2 other TNG makers to cease marketing their unapproved products. The companies, Konec Inc. of Tucson and Glenmark Generics Inc. of Mahwah, NJ have been given 90 days to halt production, and 180 days to stop shipping them.  Spokespeople from these companies said they’d comply, but insisted their products were safe.

Meanwhile Pfizer has ramped-up production of Nitrostat and claims it can handle the windfall.

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Pfizer’s Neurontin Woes Continue

April 21st, 2010 | No Comments | Source: Wall Street Journal

The jury in a Boston-based US District court case has found that Pfizer, the world’s largest drug maker, violated federal antiracketeering laws by promoting Neurontin for off-label uses. Neurontin is FDA-approved for the treatment of epilepsy, but the jury found Pfizer guilty of marketing it for migraine headaches and bipolar disorder.

Busted 300x200 Pfizers Neurontin Woes ContinueThe jury set damages at $47 million. This amount is tripled under the Racketeer Influenced and Corrupt Organizations Act, meaning that Pfizer must pay damages equaling $141 million.

The case was brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals. Kaiser alleged that it overpaid for Neurontin as a result of Pfizer’s illegal marketing tactics.

Physicians are free to prescribe drugs for non-FDA approved uses, but drug makers cannot market their products for such purposes.

Kaiser said in a statement that “that justice has been achieved for our members and the physicians, pharmacists and staff who care for them.”

Pfizer claimed that Neurontin did work in some cases, and that Kaiser still allows its physicians to prescribe the drug off-label. “We are disappointed with the verdict and will pursue… an appeal,” said Pfizer spokesman Christopher Loder.

In an unrelated case in 2004, Pfizer plead guilty to similar charges and agreed to pay $430 million to settle the matter.

Two years ago, unsealed documents from yet another case revealed that Pfizer executives suppressed the results of a 1999 trial showing that Neurontin didn’t work for chronic nerve pain at the same time the company was promoting the drug for that purpose.

Pfizer’s Neurontin marketing campaign transformed the underperforming epilepsy drug into a $2 billion per year blockbuster before generic versions became available in 2004.

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Lingering Anger over Health Reform

April 20th, 2010 | No Comments | Source: Washington Post

Anger regarding the health-care overhaul caused the number of serious threats against members of Congress to triple in the first quarter of this year, according to federal law enforcement officials.

There were 42 such threats between January and March, 2010, compared with 15 during the same period in 2009

dontmesswithhime 200x300 Lingering Anger over Health Reform“The incidents ranged from vulgar to serious threats, including death threats,” said Senate Sergeant-at-Arms Terrance W. Gainer. “The ability to carry them out is another question.”

Nearly all of this year’s threats have come from people who are opposed to health reform, although the threats are almost equally divided against both parties.

The threats have not waned since President Obama signed the bill into law on March 23; if anything, they have increased, according to an FBI spokeswoman.

In response, Capitol officials have beefed-up security at the 454 Senate offices across the country. Some offices have received special equipment to help screen mail. In other cases, new locks and surveillance cameras have been installed.

Incidents have involved House Speaker Nancy Pelosi (D-Calif.), Senator Patty Murray (D-Wash.) and Representatives Eric Cantor (R-Va.), Stephen Cohen (D-Tenn.),  Tom Perriello (D-Va.), and Bart Stupak (D-Mich.), among others.

Most lawmakers have not altered their schedules however. “It hasn’t changed how we do business in the office,” Perriello spokeswoman Jessica Barba told the Washington Post.
 
Perriello was maintaining an “aggressive public events schedule,” with a dozen appearances last week and no security accompanying him.

“There’s more anger out there about the direction of our country,” Sen. Lamar Alexander (R-Tenn.)  said. “I see it and feel it in the public meetings, but I’m going to the same places and doing the same things I always have.”

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Judge Rejects Gene Patent

April 19th, 2010 | No Comments | Source: NY Times

Last week, a federal judge threw out patents on BRCA1 and BRCA2, genes whose mutations are linked to breast and ovarian cancer. The decision casts doubt on patents covering thousands of human genes.

thyroidgenesahead1mile1 300x225 Judge Rejects Gene PatentIn his decision, US District Court Judge Robert Sweet  ruled the patents were “improperly granted” since they involved a “law of nature.” He rejected the notion that isolating a gene made it patentable, calling that “a ‘lawyer’s trick’” which circumvents the “prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The case had been brought by patients and medical organizations last May. They argued that genes, as products of nature, are discoverable and hence fall outside of the universe of things that can be patented. They also argued that patents drive up testing costs and stifle biomedical innovation.

Myriad Genetics is the company that held the BRCA patents. It markets a $3,000 test that scans for mutations in the genes which are associated with a high risk of breast and ovarian cancer.

Nearly 20% of all human genes have been patented. Enormous industries have been created around the intellectual property rights granted by these patents.

If the decision withstands a likely appeal, it might become difficult for companies to raise venture capital to support genomics research. “The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection,” said Kenneth Chahine, a law professor who filed an amicus brief for Myriad.

In that instance, “the government is going to become the funder for content discovery because it’s going to be hard to justify it outside of academia,” venture capitalist Bryan Roberts told the New York Times.

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FDA Takes Ablation Devices to Heart

April 16th, 2010 | No Comments | Source: Wall Street Journal

Last year, about 25,000 people underwent surgical ablation to treat a common cardiac rhythm disturbance known as atrial fibrillation, even though the devices used for this procedure have not been approved by the FDA for this purpose.

heartbreakingnews1 300x299 FDA Takes Ablation Devices to HeartThe market for ablation devices exceeds $100 million a year. They are nearly always used to treat atrial fibrillation, rather than the indication for which they were approved, which is to seal-off bleeding during surgery.

In atrial fibrillation, electrical abnormalities cause the upper chambers of the heart to quiver rather than pump normally. The resulting inefficient blood flow allows blood to pool and form clots in the heart, which can cause a stroke or other complications. The syndrome can also be associated with dizziness and shortness of breath.

Atrial fibrillation affects 2.3 million Americans.

Medical device companies would have to conduct expensive clinical trials to secure FDA approval for their devices as treatments for atrial fibrillation.

The Department of Justice is investigating whether companies that make ablation devices violated any laws by marketing them for non-FDA-approved uses like atrial fibrillation. Physicians can use drugs or devices as they please, but companies can only market them for FDA-approved uses.

So far, Justice has won settlements from 2 surgical-ablation device-makers. “The misuse of medical devices has the potential of exposing patients to dangerous procedures,” said Tim Johnson, US Attorney for the Southern District of Texas, after settling with AtriCure Inc. in January.

AtriCure, paid $3.8 million and another company, Estech, paid $1.5 million to resolve the claims. Neither company admitted wrongdoing.

“Clinical trials are needed to define the safety and efficacy of various surgical tools and techniques” used to treat Atrial Fibrillation, according to the Heart Rhythm Society.

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