|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 04-11-2005
Drawing a Bead on Side Effects
Drug therapy—like all medical treatments—has risks. As new technologies develop, however, researchers are giving doctors an increasing ability to mitigate those effects. Sometimes this means using diagnostic tools to monitor or identify patient groups at high risk for side effects. Other times, old drugs will be redesigned so that they are less toxic to critical organ-systems.
The battle against harmful side effects is emerging as a promising new frontier for the drug industry. Some companies..aim to remove noxious chemicals. Others hope to salvage bad drugs by improving the way the body digests them. Yet others use what they have learned about side effects to overhaul their development process. Together, these strategies could resurrect hundreds of pharmaceutical flameouts—drugs that were pulled from the market, or never made it out of the lab because of adverse reactions.
New tools for reducing toxicity gives patients and physicians more treatment options. It also helps the pharmaceutical industry by allowing it to capture revenue streams from drugs once thought expensive failures.
Let There Be Light.
Cancer drugs are by definition toxic. In fact, some of the very first cancer drugs were derived from a fearsome chemical weapon (mustard gas) used in the trenches of World War I.
Consequently, cancer oncologists face a deadly dilemma: how to use chemotherapy to kill cancer cells without killing the patient first. Researchers are addressing this problem by designing targeted cancer treatments—the medical equivalent of a precision-guided “smart bomb.” Some targeted drugs (like Gleevec) attack genetic abnormalities in cancer cells while sparing healthy organs and tissues. Other treatments use novel delivery methods to inject their fatal payloads directly into tumors. An example of this technology is a new prostate cancer drug called Tookad.
[Tookad, Hebrew for light] is an innovative twist within the established cancer drug class called photodynamic therapies. These drugs work their way through the bloodstream but become toxic only when exposed to light. When doctors shine a laser onto either the skin or an internal tumor using catheter-inserted optical fibers, the drugs kill just the illuminated tissue and leave unexposed tissue relatively undamaged.
Tookad may represent an advance over current photodynamic drugs since it “degrades easily in the liver and exits the body within hours.” According to one researcher studying the drug, “[Tookad] is one of the most promising treatments for recurrent prostate cancer after radiation I’ve ever seen.” Clinical trial results for Tookad should be available early next year.
Patients in pain keep popping pills despite FDA warning.
Imagine that you suffer from crippling arthritis pain. After years of trying drug after drug, you finally find one that helps you live a normal life. A few months later, the FDA pulls the drug from the market because 7 or 8 - or 10 - people out of a thousand may have an adverse effect after taking it. Maybe you are one of those people. But chances are, you’re not. Too bad. You will still lose access to what was, for you, a life changing treatment.
This scenario describes something of the predicament of people like Bob Starzyk, who is still taking - and hoarding - Vioxx pills months after it was withdrawn. Starzyk is a
…51-year-old truck driver from Palos Altos who says he occasionally needs Vioxx…to do his job. “I have maybe 15 to 20 left…I will take the risk to get relief,” Starzyk said. “I still have Vioxx at home, and when I get really bad I take it to keep the pain away. You can only deal with pain so much.” Starzyk is among the estimated 75 million Americans - one in four - who are living with chronic pain, according to the National Pain Foundation of Englewood, Colorado.
As we noted earlier, our current drug safety system is geared to avoid “bright line” adverse effects, rather than route patients and doctors around them, or allow them to balance their own life decisions. In an era driven by information technology and DNA testing, can’t we offer citizens like Mr. Starzyk a better way?
India Senses Patent Appeal
India is a globalization success story, and we have two articles this week chronicling how its growing economy has created new health care trends. The first article, below, notes how the Indian biopharmaceutical sector is embracing new intellectual property rights. The second chronicles India’s growing attractiveness for American and European consumers in search of inexpensive, high quality medical care.
Market-based economic reforms and an ongoing embrace of patent rights have transformed a once-poor nation into a formidable economic competitor.
Behind India’s new patent protections - which raised alarms in some quarters - is a quiet change in the country’s industry: India is becoming an intellectual-property powerhouse. The [recently enacted] amendments to India’s patent law have sparked worries that Indian companies will face chilling global competition, and that the cost of medicines would jump in poor countries now supplied by Indian generic drugs…But many of India’s most innovative companies welcome the stronger patent protections, saying they will trigger further investment and innovation in India.
It is a truism of economics that countries which persistently shield key industries from competition encourage inefficiency and waste. Countries that embrace international competition, property rights and the rule of law - like India - thrive and prosper. Europe and the U.S. should take note that India is using capitalist ju-jitsu to drive health care innovation and beat us at our own game.
Imported Canadian drugs pose security risk, report says.
A consulting firm headed by former New York Mayor Rudy Giuliani, Giuliani Partners, released a report calling for a moratorium on legislation legalizing prescription drug importation. The report, commissioned by the Pharmaceutical Researchers and Manufacturers of America, finds that
Terrorists can finance their activities by getting involved in the drug-counterfeiting business…Several Canadian mail-order pharmacies import their drugs from other countries, [the report warned], and without knowing where the drugs originated, they could have been targeted by criminals, drug traffickers, or terrorists. “Based upon what was learned about the existing system, it is not difficult to imagine a scenario in which terrorist groups could use this system to either finance their operations, or, worse, as a vehicle of attack,” the report says.
The Giuliani report lands in the midst of a heated political debate over drug importation. Many of the report’s findings, however, are uncontroversial: Canada can’t become America’s drug supplier, and current government oversight of imported drugs suffers from significant safety loopholes that can’t be closed without enormous new federal expenditures. Once shipping and regulatory costs are taken into account, savings from large scale drug importation would be very small - perhaps just a few percent at the margins. Importation is, consequently, the “Frankenstein” of policy issues - it’s a dead idea, it just doesn’t know it yet.
New Research Bolsters Tarnished MS Drug - After Withdrawal, Study Highlights Tysabri’s Efficacy
The FDA gained its mandate to ensure the safety of America’s medicines in 1938, after an antifreeze solvent used in a pediatric medicine killed 100 people. The public widely supports this basic FDA function: protecting Americans from unscrupulous or careless manufacturers. But the FDA’s role has also evolved to entail making complex safety and benefit judgments about new medicines that are inherently uncertain. For instance, as the Wall Street Journal reports
The withdrawal [of the multiple sclerosis drug Tysabri] was a blow to the 400,000 MS patients in the U.S., for whom other available treatments had been largely disappointing. Tysabri was also in the final stages of being tested for Crohn’s disease, a bowel disorder that affects 600,000 in the U.S., and was being studied for rheumatoid arthritis, a severe form of joint inflammation that affects about two million people. Many patients have expressed anger that the drug was pulled and say they would prefer to be allowed to weigh the risk themselves.
To be fair, drug manufacturers - like the makers of Tysabri or Vioxx - often pull drugs from the market to limit legal liability or avoid bad publicity. But their decisions are emblematic of how the FDA - and we as a society - have structured drug approval as a binary equation: available/not available. This all-or-nothing approach makes sense, if you want to keep antifreeze solvent out of medicines. It makes no sense when we are keeping valuable medicines from desperately ill patients, who may be willing to risk a very small chance of a catastrophic injury in exchange for a new lease on life.
Tysabri is just another example of why the FDA and its stakeholders need to formulate a drug safety regime that fits the realities - and nuances - of 21st century medicine.
A Bonus for Health, Payable to the Doctor
Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services, is a physician and an economist who is trying to redefine how the nation reimburses providers in its public health care programs.
A quiet revolution is taking place in Medicare, one that could set a new standard for the way medicine is practiced in this country. For the first time in its history, Medicare is starting to embrace an approach that has changed industries as diverse as carmakers and fast-food restaurants -- giving employees financial incentives to meet goals for quality. By the end of this year, more than 600,000 Medicare recipients will be in test programs that pay doctors and hospitals bonuses for achieving better results, like increasing the number of diabetic patients whose blood sugar is under control. Some see this experiment as the last best hope for a medical system in crisis, facing soaring costs and questions about what all that money is buying.
There are sure to be some bugs—and criticism—as the government fine-tunes the pay-for-performance model. But the fiscal crisis facing Medicare and Medicaid demands bold action, and Dr. McClellan is delivering it.
Pundits and policymakers like to rail at the high price of prescription drugs. Yet there is little understanding that the price of medicines is driven by the enormous expenditures required to develop them.
Much of this cost is due to the convoluted regulatory barriers companies must negotiate to bring new products to market:
…there is no doubt that the cost of clinical trials is high and rising fast, in turn contributing significantly to the spiraling costs of bringing a new drug to market. Bain, the management consultancy, recently estimated that total figure at $1.5 billion. Demands for multiple, more complex and longer running trials using more patients have a clear impact on cost. [Said Robert Ruffolo, head of R&D at Wyeth] “It is not uncommon to spend $10,000 to $20,000 per patient in a Phase III trial.…In cancer, it can be $100,000 per patient.”
To add insult to injury, there is little consistency between the demands of regulators in the U.S., the EU, and Japan. “To have to satisfy all three is almost irrational in an age of modern medicine.”
More good news for Genentech drug / Avastin helps those with breast cancer, clinical study shows
Genentech’s cancer drug, Avastin, is turning out to be as versatile as it is powerful.
…[the] pioneering colon cancer drug Avastin, already showing potential as a lung cancer treatment, delivered significant benefits to breast cancer patients in clinical trial results announced Friday by the company and the National Cancer Institute. In positive data that emerged earlier than expected from the late-stage study, Avastin delayed the worsening of metastatic breast cancer when combined with chemotherapy. “[Dr. Andrew von Eschenbach, Director of the NCI said that] This is an important step in our journey to ultimately eliminate the suffering and death due to cancer.”
Dr. von Eschenbach has called for eliminating “suffering and death due to cancer” by 2015. Perhaps this is too optimistic. But drugs companies like Genentech are racing to see if they can make his prediction come true.
Roche looks into heart attack test for COX-2 users.
The all-or-nothing marketing approach taken by the FDA and the pharmaceutical industry is quickly being overtaken by technologies that will help doctors give the right medicine to the right patient at the right time.
For instance, the Cox-2 drugs Bextra and Vioxx are currently off the market due to rare but potentially deadly cardiovascular side-effects in a small number of patients. But what if we had a technology that could help doctors identify those patients before they ever swallowed a single pill?
Roche Holding AG is analyzing whether one of its tests could help identify heart attack risk for users of a class of painkillers including Vioxx, which has been linked to heart problems…the company was looking at whether a tool which measures a chemical marker pointing to heart dysfunction…could also be of use used to identify Cox-2 users who are at risk of developing heart problems…Roche, the world’s biggest maker of diagnostics, believes that such tests will increasingly play a major role in the way drugs are administered by helping doctors dose correctly.
As tests like these become increasingly common, drug safety will improve and drug withdrawals—which cost companies billions of dollars in revenues—will become a thing of the past.
Are we taking too many drugs?
Poor countries complain about having too little health care. Rich countries obsess about having too much. This article, for instance, crystallizes the conventional wisdom that Americans are now immensely over-medicated.
Alice and Ken Heckman each begin their morning by cracking open a rattling plastic tray carting scores of pills in a rainbow of pastel colors. Between the two of them, they gulp 29 pills every day: a regimen of 14 drugs, with a chaser of dietary supplements. Here’s the curious part: They feel pretty hale for people in their early 70s…They each had heart fixes years ago…She has well controlled diabetes. He has worked his way through heartburn, arthritis, an enlarged prostate and occasional mild depression. Do we need all these drugs?
Are all these drugs necessary? Well, that’s a good question. The other question, however, is how much pain and disability should Americans tolerate as they age?
Duke University researcher Kenneth Manton has found that between 1982 and 1999, disability rates for Americans over age 65 fell by 25% and there were 415,000 fewer seniors in institutional care (26.3%) than expected. There are undoubtedly several factors at play here (including better overall health care), but better drugs are certainly among them. America’s seniors are healthier and more productive today than perhaps any other time in history. Every country in the world should have this “problem.”
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