|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 01-04-2005
Health Journal: What You Should Know About Painkillers Before Clearing Out the Medicine Chest
This article presents a short but very helpful overview of what we know, and don’t know, about the drug safety issues surrounding Cox-2 inhibitors and other anti-inflammatory painkillers.
Although the FDA and the NIH are now leading a review of “dozens of studies” of 18 anti-inflammatory drugs, “many scientists and public health experts think the risks for the general population have been exaggerated and that far more study is needed before we have definitive answers.” For instance, even the evidence linking Vioxx to an increased risk of heart attacks and strokes isn’t totally ironclad: “None of [the studies implicating Vioxx] were specifically designed to assess cardiovascular risk, and each involved several variables,” meaning that “it’s impossible to draw any broad conclusions for the rest of the population.”
The article goes on to note that “Every day, consumers assume serious risks when they take common drugs. For instance, taking aspirin daily to prevent heart attack puts the user at a 40% higher risk for a hemorrhagic stroke. In the real world, that translates to one additional stroke over five years for every 1,000 patients taking aspirin.”
Researchers are rushing to develop genetic and technological screens to better help patients and physicians sort through the risks and benefits of all available treatments. In the meantime, patients should consult carefully with their doctors when seeking medical treatment – and resist panic over risks that, even if present, are very, very small.
Dammed if you do, damned if you don’t. Pharmaceutical companies are donating millions of dollars in medicines and medical supplies to aid hundreds of thousands of South Asian tsunami victims, and yet one marketing executive still says that “the relief effort won’t do much to burnish the industry’s image.”
We don’t want to take issue with this article, which is just reporting the facts, but the general tone of debates over aid – and over corporate behavior generally - portrays corporate philanthropy as an entitlement, not an act of grace.
This is the wrong attitude to take. Companies are not charities. If they don’t make a profit, they go out of business. And it would have a massive knock-on effect on global health and well being if, say, R&D pharmaceutical companies suddenly decided to give away all their drugs or medical supplies for free. In other words, the philanthropic efforts of nonprofits are utterly dependent on companies who donate enormous amounts of funding, employee time and expertise, and free products to disaster relief and humanitarian efforts like this one. That money ultimately comes out of the salaries and 401k’s of their employees, or is passed along to consumers in the form of higher prices for other products. Companies may ultimately benefit from their humanitarian contributions, but the assistance itself is not without its costs and depends first and foremost on corporate profitability.
In short, the for-profit sector is not a less valuable, barely tolerated second cousin to government groups and NGOs who dedicate themselves to the public weal – capitalism is the precondition for effective, successful philanthropy. The first and best social responsibility of a corporation is to generate profits and wealth. That pursuit may not play well with anticapitalist ideologues, but it sure comes in handy when it comes time to pass the plate for international emergencies like this one.
Cholesterol Drugs Have No Effect in Fighting Cancer, It Now Seems
Despite much promising early evidence to the contrary, a new study in the Journal of the American Medical Association reports that statins do not have anti-cancer properties. But even this finding underscores the value of pharmaceuticals compared to other kinds of medical treatments: they are studied so consistently that we know more about their relative utility than we do about many other interventions.
Contrary to some researchers' hopes, cholesterol-lowering statin drugs do nothing to fight cancer, an analysis found. Researchers analyzed 26 rigorous, randomized studies involving more than 73,000 patients and concluded that drugs such as top-selling Lipitor and Zocor had no effect on cancer risk or cancer deaths. The findings appear in today's Journal of the American Medical Association.
A separate study that examined colorectal cancer alone also found the cholesterol drugs had no effect in preventing that form of cancer. That research, which appeared in the Journal of the National Cancer Institute, looked at data on more than 132,000 people enrolled in a cancer-prevention study. "We were very hopeful that we would verify there was an anticancer effect," said C. Michael White of the University of Connecticut School of Pharmacy, who led the analysis appearing in the American Medical Association's journal. "We ended up showing no change in cancer or cancer death." He said it is time to stop spending money on more studies of cancer and statins.
Still, this finding shouldn’t obscure the value of the drugs themselves, which have helped revolutionize the treatment of heart disease.
Americans Save Less Buying Canadian Drugs
In 2004, Americans purchasing Canadian drugs online saw prices go up as supply contracted thanks to drug manufacturers restricting supply to Canadian buyers. As a result, the average internet savings over American prices dropped from 38% to 29%. “To circumvent the restrictions and keep supplying their American customers, Internet pharmacies have been buying drugs from Canadian bricks-and-mortar drug stores, which charge them a markup of between 7% and 15% above wholesale prices.”
This means that Americans and Canadians are increasingly competing over the same supply of drugs, a development that hasn’t escaped the notice of Canadian policymakers. The Canadian health ministry for instance, has recently floated the idea of “[preventing] Canadian doctors from co-signing prescriptions written by American physicians, which would essentially kill the industry” or of creating “a list of drugs that can’t be exported.”
Now that drug importation is turning out to be a politically inspired mirage, maybe we can concentrate on finding real solutions that work.
AIDS Fight Shifts Fronts - Researchers Aim to Fortify Cells to Prevent Virus From Getting In
Many of the most touted AIDS drugs, including protease inhibitors, attempt to short-circuit the virus’ ability to replicate it after it has gained access to a hosts’ cells – a strategy this article dubs “battling the enemy inside the fort” rather than outside the gates.
However, several pharmaceutical companies are rushing to develop a new generation of AIDS drugs that will block the cellular pathways that HIV uses to gain access to the cell’s inner sanctum. Two of these pathways are “docking stations on the cell surface that eventually allow the virus to get inside.” The most common docking station for the HIV virus is called the CCR-5 receptor; less common viral strains bind with the CXCR-4 receptor or can bind to both sites. While the current crop of antiretroviral drugs are very effective, and have dramatically improved the life expectancy of AIDS patients, the virus is continually mutating and developing drug resistance, “so new treatments are always needed.”
Pfizer is developing a CCR-5 blocker, UK-427, which is currently in late-stage human studies. GlaxoSmithKline PLC and Schering-Plough also have CCR-5 compounds in testing, although neither is as far along as Pfizer’s. Another company has a drug in development that blocks the CXCR-4 site.
“Researchers and the companies expect the CCR-5 blocking pills, if approved, to be part of a multidrug regimen, not treatments that would be used alone. The best case scenario would be for these drugs to be used alongside one that blocks the other pathway, CXCR-4.”
Malpractice Bill Shields Drugmakers
Imagine you are a business owner. You follow all relevant government regulations and obey the law scrupulously. Then one day, one of your products is accused of harming a consumer. Assuming that you are found liable for compensatory damages in court, should the plaintiff also be able to ask for punitive damages, i.e. accusing you of acting negligently and recklessly? Or, to put it another way, “if you have done everything the law requires, why should you be punished?”
Without some safe haven for regulatory compliance, the risk is that legitimate companies, especially small companies and entrepreneurs, will increasingly shy away from medical markets where liability risks are massive and unpredictable.
However, a small provision in a medical malpractice bill pending in Congress that would protect pharmaceutical companies from punitive damages if they comply with all FDA regulations is becoming increasingly controversial. The provision doesn’t cap compensatory damages, or deny claimants access to the courts: it just protects companies from punitive damages if they obey all the relevant FDA regulations.
Protection from punitive damages for responsible companies who operate in an industry that provides critical medicines that improve the health and well being of millions of people around the globe should be a no-brainer. However, tort lawyers will try and use recent safety concerns about Cox-2 drugs to demagogue the bill, playing on public fears and obscuring the real issues at stake.
Hopefully, this is one time when their power-play will come up short.
DNA helping Lilly bank on future cures
Human beings share 99.9% of their DNA. The remaining .1% (in conjunction with various environmental influences) may hold the key to unlocking the origin of illnesses like Alzheimer’s and cancer, and explain why some cancer drugs only work in a handful of patients. Unlocking those mysteries is one reason companies like Eli Lilly are storing biological samples from thousands of patients in hopes that, over time, new tests that study and compare genes, proteins, and other molecular signatures of disease will allow the company to develop personalized medicines that are safer and more effective than traditional treatments.
Lilly has built up its human DNA bank over the past four years in hopes of tapping it to get new insights on the ways drugs interact with humans. The elusive but promising goal, which still may be years off, is to zero in on how to "personalize" drugs to make them more effective in treating diseases in more people.
Lilly's vice president of early clinical development, Dr. Eiry W. Roberts, describes it as "delivering the right drug at the right dose at the right time." "It really frames a lot of our internal work currently," she says.
The "combined specimen bank," as Lilly calls it, became a worthwhile endeavor only with the coming of the human genome project in the 1990s. The government and private effort has begun to sort out which genes control which functions within the body. "We can now look at materials in ways we never could before," says Eric Meslin, director of the Indiana University Center for Bioethics.
But the development of these new medicines hinges on an FDA - and Congress - that is willing to embrace new methods of testing and evaluating new treatments. This may not happen, however, as long as some pundits and policymakers insist on demonizing the industry and threatening it with price controls. If price controls threaten the industry’s profitability, the investments needed to bring personalized medicines to market may evaporate.
Two Studies Suggest a Protein Has a Big Role in Heart Disease
Scientists have discovered a new biomarker that may play a critical role in the development of heart disease – perhaps an even more central role than that currently attributed to cholesterol. “Reducing the levels of [C-reactive protein or CRP] secreted by the body may be as powerful a tool in slowing heart disease and preventing heart attacks and cardiac-related deaths as lowering cholesterol, two teams of researchers are reporting today.”
The studies, published in The New England Journal of Medicine, followed “patients with severe heart disease who were taking high doses of statin drugs, which reduce both cholesterol and CRP. Lower CRP levels, the researchers found, were linked to a slower progression of atherosclerosis and fewer heart attacks and deaths.” Most notably, “this effect was independent of the effect of lowering cholesterol.”
While more research is needed to understand the direct role, if any, CRP plays in heart disease, some cardiologists are already recommending that CRP levels be measured in addition to cholesterol. Said one researcher: “There is a huge payoff if doctors understand that they need to test not just for cholesterol but also for CRP. . . . That alone will save tens of thousands of lives right there.”
New Test May Detect Parkinson's Early, Aid Search for Drugs
A new speech test may enable doctors to identify Parkinson’s patients years before the disease has killed enough brain cells to express its classic symptoms: “trembling in the limbs, difficulty controlling movement, and…paralysis.”
The test, developed by Pfizer, “[analyzes] how people speak”, since areas of the brain controlling small muscles, like vocal chords, are affected before those controlling larger muscle groups involved in walking. If additional studies validate the speech analysis test, physicians will have access to a simple, relatively inexpensive method of diagnosing Parkinson’s patients before irreparable harm is done, and can use the test as a screen to measure the efficacy of new potential treatments.
“As things stand now, the lack of a standard test for Parkinson’s, like blood sugar for diabetes, stymies efforts to gauge the effect of experimental drugs.”
A Quandary in Good News
The revelation that C-reactive protein [CRP] is a biomarker for heart disease has thrown another strand into the already tangled web of data on Cox-2 inhibitors like Vioxx and Celebrex. This is because while some Cox-2 drugs are under suspicion for possibly raising heart attack and stroke risk for some patients, they are also anti-inflammatory drugs that have been shown to lower CRP levels.
“For example, Vioxx, which was pulled from the market in late September because of those risks, had been found in a study just a month earlier to cut CRP levels in half, from the danger zone to a level considered excellent. Celebrex, still on the market but linked to an increased risk of heart attack, has also been found to lower CRP levels.”
What are we to make of these findings? Nothing, yet. The problem physicians, regulators and patients face is that clinical trials usually only focus on a very narrow range of clinical data and outcomes. Untangling the full relationship between anti-inflammatories and heart disease won’t happen until we design better clinical trials that collect baseline genetic data at the individual level and correlate it with biomarkers like CRP and cholesterol. Then we can track responses to different treatment regimens, including Cox-2 inhibitors or statins, and pinpoint the mechanisms behind different adverse drug events or health improvements.
This will allow us to build a bottom-up picture of heart disease and drug treatment, as opposed to the confusing hodge-podge of isolated facts bombarding us now.
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