In the Spotlight
FDA Drug Officers: Working in the Dark
Information technology can revolutionize drug safety monitoring.
Dr. Scott Gottlieb, Center for Medical Progress, 2-3-05
If Congress and critics are looking for the real Achilles heel behind the agency's recent drug safety woes, the answers don't rest with the apple-polishing agency whistle blower David Graham or the pecking order that the drug safety office occupies inside the FDA's internal bureaucratic hierarchy.
Rather, the FDA’s glaring inadequacy is the woefully outdated computer system hobbling its medical review staff.
Investors who were holding the stock of a biotech company called Neurocrine Biosciences recently got a fast education in the problems that make the drug safety issue a hard nut to crack.
Continue reading . . .
Germ Reports Some Push to Make Hospitals Disclose Rates of Infection: Aim Is to Empower Consumers, Spur Prevention, but Critics Cite Host of Complexities
Wall Street Journal, 2-1-05
Every year, millions of patients will develop serious infections during their treatment in U.S. hospitals, according to the CDC. “It says that these may lead to nearly 90,000 deaths annually—more than the toll from breast cancer or car crashes. Hospital-acquired infections add roughly $5 billion a year to the cost of patient care in the U.S., according to a study in the American Journal of Infection Control in 2002.”
As a result, there is a growing movement to require hospitals to disclose their infection rates and “laws requiring hospitals to compile and publish their infection rates have recently passed in Pennsylvania, Illinois, Florida…and Missouri.”
Requiring hospitals to publish standardized, risk-adjusted infection rates in a transparent medium would give patients and the physicians who refer them for hospital treatment the ability to avoid bad performers and demand more safety procedures to ward off infection. The CDC is helping with this effort and is trying build consensus on a national infection reporting program—and may use as a model New York State’s successful experience “reporting on hospitals’ mortality rates in coronary-artery bypasses.”
Of course, some hospitals would prefer to keep such information private, out of fear of lawsuits, or because they are worried that they will be penalized for taking hard to treat patients, who may be at very high risk of infection (like, say, AIDS patients).
But it is possible to adjust reporting laws to take these issues into account and empower consumers to demand safety reforms.
Arthritis Drug Study in 2000 Found Risks; Results Show Pfizer May Have Known About Celebrex's Heart and Stroke Problems
Washington Post, 2-1-05
The consumer advocate group Public Citizen has recently accused drug giant Pfizer—and Pfizer’s former partner, Pharmacia—of hiding data from a 1999 study that associated Pfizer’s COX-2 drug Celebrex with an elevated risk of “heart attacks and other cardiovascular side effects.” The 1999 clinical trial was only recently posted on a clinical trial’s website.
Still, the initial furor around the study seems to be more about the failure to publish the study sooner than any link between Celebrex and heart disease. According to one of the safety-board members who oversaw the trial, “The Public Citizen analysis was flawed…because it lumped together side effects that could have different causes. In some cases…the same patient might have been counted more than once as well. And it happened by chance that the patients in the Celebrex groups were sicker overall than those in the placebo group.”
Still, this is one more argument that the industry badly needs to regain public trust by doing more to encourage rapid disclosure of significant clinical trials, no matter what the results. The absence of transparency (or even a voluntary system) is sure to invite skepticism and suspicion when companies are least able to afford it. After all, the time to protect your reputation is before a crisis—not after one develops.
Nanomedicine's Promise Is Anything but Tiny
Washington Post, 1-31-05
Nanotechnology—the study and art of manipulating matter on a molecular or atomic scale—will redefine medicine in the coming decades, as diseases are cured or prevented by tiny devices and medicines that repair the human body at the cellular level.
For the time being, nanomedicine is more science fiction than science fact, but there have been some very promising early developments. For instance, researchers are using “quantum dots” (tiny bits of silicon, 2-billionths of a meter long) as “research tools to help them understand how proteins, DNA and other biological molecules catch rides on the various transportation systems inside cells” and to help diagnose disease at the molecular level.
Other “nano” devices may be used for cancer treatment—for instance “photo-thermal nano-shells…gold coated spheres about 130 nanometers in diameter.” These spheres are great at absorbing infrared light that penetrates the human body but is harmless under normal circumstances. However, researchers found that when they infused the nanospheres into mice with cancer, the spheres accumulated around tumors and, when bombarded with infrared light, heated up to 122 degrees—effectively cooking the tumors and killing them. “Months later, the animals were still cancer free.”
The promise of nanotechnology is enormous—but can we embrace it? Currently, the FDA is struggling to develop protocols for tracking traditional drugs, in traditional settings—let alone cutting edge forms of nanotechnology or genetic medicine. Making the leap into the 21st century will require enormous imagination and flexibility from an agency that faces ruthless criticism every time it does something flexible or original.
List saves much-needed Medicaid money, but some say it's too restrictive
Associated Press Newswires, 1-29-05
Not all drugs are created equal, right? Some are better, more cost-effective or safer, than others. So why not save government money and only allow doctors in public health care programs to prescribe “pre-approved” drugs that are the cheapest and most effective for the average patient?
Michigan started its own prescription drug pre-approval system in 2002. The system forces doctors to “get authorization from the state or its drug contractor First Health Services Corp. before a Medicaid patient can get a prescription filled for drugs that are not pre-approved.”
Some doctors are critical of the plan, complaining that patients must fail on pre-approved treatments before they are allowed to progress to more effective medications—a process that is irksome for doctors and patients that don’t fit the state mandated mold. Doctors also complain that their inability to easily prescribe other medicines drives up health care costs by prescribing treatment twice—once for the pre-approved medicine, and again for the drugs the patients really need.
Still, “Limiting prescription drugs for 500,000 Medicaid recipients has saved the cash strapped state more than $20 million so far because drug companies must provide deep discounts to be available without prior authorization.”
Are cost concerns trumping better health care for Michigan’s Medicaid patients? This is the heart of the dispute. In short, cost is “the elephant in the room that no one is talking about.”
The state has responded by pointing out that the vast majority of requests for authorization are approved. Critics (including doctors, drug makers, and consumer advocates) respond that “doctors with large caseloads and a high number of insurance-related requirements may see the authorization process as a nuisance to avoid…Physicians are more reluctant to prescribe drugs with a prior authorization because it’s more paperwork for them. It’s a hassle.”
In other words, many doctors who would otherwise prescribe patients a different drug just shrug their shoulders and give up. This certainly drives down costs but at the expense of physician autonomy and patient health.
Report on Eli Lilly Is Retracted
Wall Street Journal, 1-28-05
As we noted last week, the British Medical Journal (BMJ) ran a report accusing Eli Lilly of hiding data from the FDA for more than a decade that linked Prozac to a heightened risk of suicide and violent behavior. This week, the BMJ retracted its report (based on an anonymous source) and issued an apology.
“The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims…The BMJ is happy to set the record straight and to apologize to Eli Lilly for this statement, which we now retract, but which we published in good faith.”
Perhaps with good faith, but not good journalism, if the BMJ didn’t do the due diligence required to support these anonymous claims prior to publication.
The public is often frustrated when corporations are slow disclosing information, or reluctant to comment on health or safety issues affecting their products. However, corporate managers are painfully aware of how their comments affect the threat of product liability suits, shareholder value, and their duty to protect proprietary information. On the other hand, those who make claims against corporations don’t face similar hurdles, and claims of corporate wrongdoing are often taken at face value—for better or worse. Still, both BMJ and Eli Lilly will survive this incident with minimal scarring.
However, one also wonders what cumulative effect stories like this have on doctors and their patients suffering from depression—who are probably more leery than ever of taking Prozac or other antidepressants. That harm is real and lasting.
Novartis Breast-Cancer Drug Lowers Tumor Risk in Study
Wall Street Journal, 1-27-05
Novartis’ new breast cancer drug (Femara) continues to outperform the standard treatment, tamoxifen, that has been in use for decades. A new study has found that the drug “significantly reduced the risk of a tumor growing back” after surgery, and lowered the risk of metastatic cancer. These findings are the “latest in a wave of research supporting Femara and similar drugs known as aromatase inhibitors.”
Novartis’ study followed postmenopausal women with early breast cancer for a median length of 26 months after initial surgery. Patients on Femara had a 19% lower risk of cancer recurrence and 27% lower risk of developing metastatic cancer compared to tamoxifen.
Bush Promotes Health Savings Accounts; He Says Plan Would Cut Insurance Costs and Increase Patient Responsibility
Washington Post, 1-27-05
President Bush is advocating a variety of markey-based reforms to contain health care spending, increase the availability of health insurance, and improve the use of information technology in health care settings.
At the core of his plan: “proposing tax credits to encourage expansion of health savings accounts and calling for allowing small businesses to pool together for health coverage across state lines.”
Critics have alleged that market forces will only exacerbate America’s health care crisis, and force poor or sick patients to go it alone. However, America already has a huge subsidy for poor patients—Medicaid—and yet millions of people still forgo access to medical care while government health care spending rages out of control.
The trick is not to keep people out of markets, but to find ways to get them back in. Millions of Americans will benefit from national insurance markets, Health Savings Accounts, and more IT technology in healthcare. Will this be the last word in health care reform? Probably not. But if coming generations have more responsibility for their own health care, and bear more of the costs for routine care, they will have powerful incentives to eat right, exercise, and their spend health care dollars frugally.
That may not solve all of our problems, but it’s the right start.
The Vaccine Balance
The New York Times, 1-29-05
GlaxoSmithKline is marketing a vaccine first in a very unlikely place – Mexico. Europe and the U.S. are usually the markets of choice for manufacturers of new drugs and vaccines, because of our lavish spending on health care.
Where the profits are, the medicine follows. Still, this vaccine, which immunizes children against rotavirus infection, is desperately needed in the developing world, where the virus kills hundreds of thousands of children every year due to dehydration from vomiting and diarrhea. Thus, Glaxo’s decision to market the vaccine in Mexico represents something of a sea change in industry practice.
“Glaxo plans to extend [Rotarix, the rotavirus vaccine] to other Latin American countries and Asia by the end of the year. It has applied for approval in Europe and will eventually do so in the United States….Glaxo is speeding the vaccine directly to where it is most needed. It’s a long overdue step that makes perfect sense.”
Why is this “long overdue step” finally happening? To paraphrase the film Field of Dreams: if you build a market, supply will come. Thanks to enormous funding from the Gates Foundation, “the Global Alliance for Vaccines and Immunization…is giving the poorest countries a pot of money to buy vaccines and assuring manufacturers of a market.”
However, we shouldn’t forget that the FDA and the European Medicines Agency are still the gold standard for drug regulation. An earlier rotavirus vaccine, made by Wyeth, was pulled from the American market because of the possibility of a rare side effect that might kill 1 in 10,000 children. In a rich country, where few children die from diseases like this, this may be a sensible decision. However, in poor countries the risk to reward ratio is completely different—while waiting for Glaxo’s vaccine, tens of thousands more children died because Wyeth’s was pulled from the market.
The FDA and EMEA should step forward with an approval process that gets treatments for diseases in poor nations out as quickly as possibly, while identifying rare potential safety problems that might be fixed or ruled out through additional research. We should treat vaccines for diseases in developing nations the same way we treat cancer drugs for American patients—if no other treatments are available and the choice is between death and a rare side effect, it is always better to risk the side effect.
Delivering on the AIDS fight
Chicago Tribune, 1-28-05
The Tribune praises President Bush for his ongoing commitment to fighting AIDS in developing nations, including the recent FDA approval of the first generic combination AIDS drug for purchase by the Presidents Emergency Plan for AIDS Relief. Says the Tribune: “No other president, or country, has done more to fight AIDS worldwide than Bush and the U.S.”
A cornerstone of the President’s plan has been the demand that generic medicines used to fight the disease should meet the same standards that we use to evaluate patented drugs sold in the U.S., and the FDA has responded by promising to evaluate data submitted by generic manufacturers quickly and free of charge. Other generic companies should follow suit and patient advocate groups should get over their fruitless sniping against research driven pharmaceutical companies.
The battle against AIDS in developing nations is a two-front war where both generic and patented medicines have critical roles to play in overcoming the disease.
Wall Street Journal, 1-2-05
Maybe Jeb Bush will never run for President. Still, Florida’s Governor is showing real presidential vision with his plan to address Florida’s Medicaid crisis.
“Over the past six years, Florida’s spending on Medicaid has grown at an average of 13% a year while service has worsened…One quarter of the state’s budget already goes to Medicaid, a figure that, if left unchecked, is projected to hit 59% in 10 years.”
And Florida isn’t alone: every other state is facing rapidly rising Medicaid costs, if not an outright crisis. Why? “From the consumer’s perspective, Medicaid is a nearly incomprehensible maze—which explains in part why so many participants head for expensive hospital emergency rooms when they need routine treatment.”
Governor Bush’s proposal: infuse Medicaid with consumer choice, “starting with letting participants decide how to spend the money allocated on their behalf. Each participant would be assigned a premium with which to purchase coverage for basic and catastrophic care. Options would include HMOs, insurers, and community-based networks of physicians and hospitals. Premiums would be risk-adjusted, which is to say that someone with AIDS…would receive a higher premium than a generally healthy person.” Patients who complied with doctors orders would even earn extra subsidies in flexible spending accounts that they could take with them when they leave Medicaid and use to defray other health expenses.
In short, Florida’s program has the potential to become a national model for how the government provides health care to its poorest citizens through market incentives and personal empowerment.
Rofecoxib Increases Risk for Acute MI; Higher Doses Further Increase Risk
Medscape , 1-31-05
A study in the Annals of Internal Medicine recently posted online found that “rofecoxib (Vioxx) increases the risk for acute myocardial infarction, and risk increases further with higher doses.”
The study used a “time-matched, nested, case-control approach and Quebec’s administrative health databases” to evaluate 113,927 elderly patients without previous heart disease who began NSAID treatment between January 1, 1999 and June 30, 2002. The researchers also noted that “there were not increased risks associated with use of celecoxib…or the other NSAIDs” followed in the study.
The authors concluded that “new agents with COX-2 inhibitory potency similar to or greater than that of [Vioxx] should be used only with extreme caution, even in populations at relatively low risk for cardiovascular events.”
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