Biopeer

Some riddles of the heart explained

In the last week, scientists have made important discoveries regarding cardiovascular problems.

While it had been widely accepted that certain Cox-2 inhibitors prescribed for arthritis increase the chances of heart attack, for the first time a study has shown the reason behind this. In a collaborative effort, researchers from different universities in London have found that these inhibitors block the enzyme Cox-1. Due to this, it is unable to produce prostacyclin, the agent that thins the blood. As a result, blood clots are formed and increase the likelihood of heart attacks and strokes. The researchers are hopeful that their findings will assist the development of Cox-2 drugs without these side effects.

In an attempt to put to rest the doubts about the benefits of folic acid for heart disease, Dr David Wald and his team conducted a study where they found that homocysteine concentrations do contribute to heart attacks and as folic acid lowered these concentrations, increasing its intake would reduce the chances of one suffering from a heart attack. However, they agree that the scope of the study was very small and clinical trials will be better able to justify their findings.

Across the channel, in the USA, researchers have found that people at moderate risk of heart attack would be extremely benefitted if they take statins to reduce their cholesterol, even if they do not suffer from any cardiovascular disease. Dr Niteesh K Choudhry, from the Brigham and Women's Hospital, Boston, examined studies of 48,000 patients and found that statins reduced the occurence of major cardiovascular problems like heart attack by 29 per cent when compared to a placebo. With the price of statins falling, the researchers are of the opinion that the benefits far outweigh the cost.

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Studies link painkillers to heart disease

Studies have found that certain widely used painkillers increase the chances of renal and cardiovascular problems.

An analysis of 114 studies involving over 116,000 people conducted by researchers at the Harvard University has indicated that taking rofecoxib, a COX-2 inhibitor, raised the odds of renal problems and arrhythmia. Merck & Co Inc used to sell rofecoxib under the brand name of Vioxx. However, the company had withdrawn the drug in September 2004 when a three-year study showed that Vioxx doubled the risk of heart attack and strokes in patients who took Vioxx for at least one and a half years. Analysts at JP Morgan Securities believe that the recent findings may encourage many Vioxx users to file lawsuits against Merck.

Another study has found that the pain reliever diclofenac is as risky as Vioxx and should be avoided by heart patients. Sold under the names of Cataflam and Voltaren, it increased the patients' likelihood of having a heart attack by 40 per cent. Another COX-2 Inhibitor, Celebrex, was not dangerous at the recommended doses of 200 mg or less. However, it cannot be denied that previous studies have found it to be risky when taken in 400 mg doses. The researchers have also determined that Naproxen, sold as Aleve and as Naprosyn, showed no cardiac risk.

Meanwhile, researchers at the University of Pennsylvania School of Medicine have discovered that removing an inflammation enzyme in a mouse model of heart disease slowed and stabilized atherosclerosis. The researchers believe that their findings will pave the path for a new class of nonsteroidal anti-inflammatory drugs (NSAIDs) that will not promote heart disease.

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Painkillers affect heart adversely

A recent study has found that non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and diclofenac increase the risk of heart disease. This comes as a major blow to sufferers of acute chronic pain as these drugs are extensively used as a source of relief.

Researchers from the University of Oxford and the University of Rome found that consuming these drugs in the highest recommended dose could double the risk of heart attack. The study was published in the British Medical Journal.

The researchers collected the outcomes of all trials in which vascular events had been recorded for both COX-2 inhibitors and NSAIDs. They found three more heart attacks per 1,000 people every year among subjects who did not already have heart disease, but who were taking COX-2 inhibitors or NSAIDs. Dr Colin Baigent, who headed the research, said that the study was carried out over several years and involved 140,000 patients. When all “vascular events”—heart attacks, stroke or vascular disease—were considered together, the drugs increased the risk by 40 per cent. On the other hand, naproxen was found to be safe while aspirin was not included in the analysis.

An earlier study had confirmed that COX-2 inhibitors were responsible for the increase of vascular events. This had led to Vioxx being withdrawn from the market. With the latest study establishing that NSAIDs also increased the chances of heart failure, sufferers from painful conditions like arthritis claim that the respite given by these drugs is worth the risk. The researchers have also reassured the people saying that the heart attack rate is small and there is no need to panic.

Hope for colorectal cancer patients

Colorectal cancer is a term used to describe cancers of the colon (the large intestine or bowel) and rectum. Together, they comprise one of the most common cancers in the world. A recent study has shown that people who smoke and drink contract the disease earlier than others. Studies have earlier shown that lifestyle changes, made by reducing the intake of alcohol and cigarettes, reduce the overall chances of cancer.

New developments in the field of medicine have shown hope for people affected by this deadly disease. According to a new study conducted by the Ghent University Hospital, Belgium, the phase III trials for a new drug have shown promise in extending survival of patients with advanced form of colorectal cancer that has spread to other parts of the body. The new drug, named Panitumumab, targets a growth factor receptor that is a key player in cancer cell growth and improves progression-free survival in patients. The drug is manufactured by Amgen Inc and is waiting for approval from the USFDA for sale in the markets.

Another controversial research has highlighted the benefits of Cox-2 inhibitors, such as Celebrex, in protecting patients from developing colon cancer. The drug blocks a critical element, called polyps, that is associated with inflammation, as well as tumors. But the only problem in administering the drug is that it increases the risk of heart attacks among individuals taking it, thus making it a risky recommendation. 

Pharma company, Pro-Pharmaceuticals Inc, is also planning to start its late-stage clinical trial for its Davanat cancer treatment, which has been found to be quite effective in mid stage clinical trial for patients with colorectal cancer. All in all, a range of effective treatment forms are being developed to help people successfully combat this serious ailment.

Commentary on COX-2

Vioxx and Bextra are off the shelves.  Celebrex can't be far behind.  What happened?  That is beginning to become clear, but the next question is what are the pharmas going to do about it?  What does this mean for R&D, profits, marketing, and taking chances?  John Mack is trying not to gloat and saying "I told you so..." but well he did have a point--Pharma Marketing Blog- Cox-2's (and Pfizer?) on Slippery Slope.

 

What do you think pharma's solution should be?  And what's next?

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Americans mad at the FDA not drug makers for Vioxx scandal

A study released last week by Ipsos Ideas and the AP states that Americans are more upset with the FDA for not dealing with Vioxx and other COX-2 inhibitors than the drug makers themselves.  Americans feel that the FDA should be doing a better job of protecting them.  The rhetorical question in this though is, if the drug makers aren't fully disclosing trial results and other data, how can the FDA do its job?

Ipsos Ideas: Vioxx Recall Hurt Americans' Confidence in FDA, Not Prescription Drugs

NEW YORK, March 09, 2005 /PRNewswire/ -- Consumer response to concerns about COX-2 inhibitors Celebrex, Vioxx, and Bextra was emblematic of how informed health consumers are changing pharmaceutical manufacturers' susceptibility to shifts in public opinion, consumer confidence, and corporate credibility. Despite the hype, Americans are more confident in safety of prescription drugs than they are in the Federal Drug Administration's ability to ensure safety with use.

The deeper question that this raises is how far can the FDA go to push drug makers to disclose these data?

The COX-2 scandal has left many people scrambling for treatments for their chronic pain, Merck has been badly damaged and other makers of COX-2 products tainted by association.  So what is the role of the researcher in this?  Is there not a moral obligation to disclose a problem like this when it comes to light or is the whole problem really one of drug surveillance and data analysis.

As compounds become more complex, more "selective" in pharmacology, I think it is imperative that pharmaceutical companies do more to be able to quickly take adverse event reports and other surveillance data and apply it to the greater understanding of a particular compound or molecule.

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