In the Spotlight

Cancer patients are paying for the FDA's caution.
Why narrowing accelerated approval costs lives.

Dr. Scott Gottlieb, Medical Progress Today, 5-27-05

Accelerated approval for cancer drugs at the Food and Drug Administration just got a lot slower.

Accelerated approval regulations essentially allows the FDA to approve drugs that treat unmet medical conditions (such as many advanced stages of cancer, for which there are currently no effective therapies) based on the results of early stage (Phase II) data.

Continue reading . . .

Featured News:
CVS Will Try to Close One Gap Where Counterfeit Drugs Enter
Wall Street Journal, 5-25-05
Featured Commentary:
The FDA vs. Cancer Patients
Wall Street Journal, 5-19-05
Featured Research:
Statins and the Risk of Colorectal Cancer
New England Journal of Medicine, 5-26-05


Why Patients Fail to Take Their Medicines
Forbes, 5-25-05

Editor’s Notes:

Most U.S. health care spending is absorbed by a relatively small number of patients—for instance, about 25 percent of Medicare beneficiaries account for nearly 90 percent of the program’s expenditures.

Studies suggest that the most expensive patients have may multiple, chronic health conditions that are poorly controlled. For instance, this article notes that patients at high risk for heart disease—and who need medicines to control both high blood pressure and elevated lipid profiles—don’t take their medications as prescribed.

Reporting in the May 23 issue of the Archives of Internal Medicine, researchers at ValueMedics Research, in Arlington, Va., analyzed a managed-care organization's database, identifying more than 8,400 patients who'd been prescribed both anti-hypertensive and cholesterol-lowering medications. They then tracked each patient's adherence to the drug regimens for an average of almost 13 months.

Three months after starting their treatment regimen, just 44.7 percent of patients were still adhering to it, with that number dropping to just under 36 percent at both the six-month and one-year mark. [Ed: emphasis added.]
At the same time, the researchers found that between 25.3 percent and 29.6 percent of patients were taking one drug properly as prescribed, but failing to adhere to instructions for the second drug.

The study suggested additional protocols that doctors could follow to increase patient compliance. But it should also be noted that doctors aren’t paid for monitoring compliance—they’re paid for seeing patients.

Improving disease management for hard-to-treat patients means not only getting better data on patient compliance, but also moving away from the fee-for-service health care model that focuses payments on acute care (i.e., hospital and doctor’s office visits) rather than careful management of chronic illnesses.


CVS Will Try to Close One Gap Where Counterfeit Drugs Enter
Wall Street Journal, 5-25-05

Editor’s Notes:

Consumers usually assume that the drugs they take go right from the manufacturer to their local pharmacy. They don’t. They pass through many layers of wholesalers, large and small, who are regulated—often poorly—at the state level. Wholesalers profit on the differential between their initial purchase price and the final sale price to hospitals, pharmacy benefit managers, and pharmacies.

Lax state regulations and high profit margins on pharmaceuticals have lured criminals and counterfeiters into the wholesale market, with potentially deadly consequences for American patients. (For more information on how the wholesale drug market has become corrupted see the excellent book Dangerous Doses, by investigative reporter Katherine Eban.)

While lawmakers in Congress and in individual states are debating new regulations for wholesalers, pharmacy chains like CVS are moving to protect their customers by buying directly from the manufacturer or other trusted sources.

Lawmakers, drug makers and wholesalers have been grappling in recent months with what they say is a growing problem with counterfeits, on the rise due to a growing influence of organized crime and the ease of using the Internet to sell the drugs. Several states, most notably Florida, are working on "drug pedigree" legislation to track drugs from manufacturer to retailer. … CVS said that some of the legislative initiatives are "impractical," and that the company's action was a way to address patient safety.
CVS's decision is the latest industry effort to eliminate gaps allowing counterfeit drugs to get to consumers. Earlier this month, drug wholesaler Cardinal Health Inc., of Dublin, Ohio, said it will buy drugs only from manufacturers or other authorized sources. CVS is Cardinal's largest customer, accounting for 18% of Cardinal's revenue last year. A spokesman for Cardinal said its decision was unrelated to CVS's.

Drug manufacturers are also working on new technologies to deter theft and detect counterfeit drugs. In the meantime, consumers should seek out pharmacies like CVS that can verify the source of their medicines.


The Boston Globe, 5-25-05

Editor’s notes:

Depressive disorders affect about 19 million American adults today. Unfortunately, although many treatments are available, patients often have to try several medicines before they find an effective medication or dosage—prolonging suffering and adding to overall health care costs.

Boston Scientific, however, will help market a technology that could help doctors see how treatments for depression—and even Alzheimer’s—act in the brain, allowing them to find better treatments faster.

Boston Scientific Corp. yesterday said it will pay $25 million to Aspect Medical Systems Inc. of Newton for work on brain-monitoring devices that could help doctors select drugs to treat depression and Alzheimer's disease. … Aspect chief executive Nassib Chamoun said the devices could conceivably make it easier to detect and treat early signs of Alzheimer's, though treatment options are still limited to a few drugs like Pfizer's Aricept. Treating patients with depression might be a more lucrative market, Chamoun said, because the devices could help doctors determine how patients respond to various drugs. Data suggest they could also be used to predict which patients would be at risk of suicide brought on by antidepressants. "That is where the opportunity is, and why Boston Scientific is interested," Chamoun said.


Drug Helps to Reverse Vision Loss
Wall Street Journal, 5-24-05

Editor’s Notes:

Age-related macular degeneration (AMD) “is the leading cause of irreversible vision loss among the elderly,” and until now, there have been few good treatments available. A new drug from Genentech called Lucentis, however, is giving fresh hope to AMD patients with the most aggressive form of the disease.

An experimental drug from Genentech Inc. improved vision, on average, for patients with a degenerative eye condition, the first time any therapy has appeared to reverse the malady in a large clinical trial.

In a test of 716 patients with a particular form of age-related macular degeneration, Genentech's injectable drug Lucentis produced an average improvement in vision for the patients getting the drug. Patients who received sham injections during the study, by contrast, showed a decline in visual acuity, on average. Overall, Genentech said, fully 95% of patients who received Lucentis saw their vision stabilize or improve, compared with 62% in the control group.
The results exceeded expectations at the company and among eye specialists, who have long sought a way to treat AMD more effectively. "That is huge," said Elias Reichel, a researcher at Tufts University who participated in the study. "This is going to benefit large numbers of patients."

Ironically, Lucentis is actually a “modified form of Genentech's cancer drug Avastin,” proving that innovations in one area of medicine often have spillover benefits unrelated to their original use.


Crestor has higher incidence of side effects; A new analysis showed that certain important side effects are more common with Crestor than with other cholesterol drugs. But doctors said most users should stay on the drug. SCIENCE & MEDICINE
The Miami Herald, 5-24-05

Editor’s Notes:

The consumer group Public Citizen has called for the withdrawal of a widely used cholesterol-lowering statin called Crestor, on the grounds that it is significantly more dangerous than other drugs in its class. However, a new report actually makes the case that Crestor “should [still] be considered safe for long-term use.”

The new findings suggest that Crestor, whose generic name is rosuvastatin, probably should be reserved for patients who have a hard time lowering their overall cholesterol levels with other statins, said Dr. Richard H. Karas of the Tufts-New England Medical Center in Boston, who led the study. …
Comparing the number of reported events to the number of prescriptions written, the Karas team concluded that Crestor was responsible for 2.2 times as many reports as simvastatin, sold by Merck under the brand name Zocor, and 6.8 times as many as atorvastatin, sold by Pfizer under the brand name Lipitor.

The relative risk makes Crestor sound pretty dangerous—until you read that the absolute risk from Crestor was small: 145 complications out of over 5 million prescriptions. This translates into “an absolute risk of one in 35,862.”

Getting information about the relative risks and benefits of medicines is critical—but it is also important that those risks are put in context and that doctors and patients have a wide variety of treatment options.

For instance, patients at high risk for heart attack who aren’t responding to other statins should have the option of taking a one in 36,000 risk of a rare complication.


Insurance Option Has Workers Pay More
Los Angeles Times, 5-23-05

Editor’s Notes:

Health savings accounts linked to high-deductible insurance plans are spreading among employers and employees who are trying to rein in high health care costs and premiums.

Now, as medical costs keep climbing, those high-deductible plans are spreading to the giant corporations that have long been the backbone of traditional job-related, low-deductible health insurance. And if the trend continues, it could reshape the medical insurance landscape and sharply redistribute costs, risks and responsibilities for many of the 160 million Americans with private coverage.
A number of large employers, including defense contractor Northrop Grumman Corp., the Wendy's hamburger chain, high-tech conglomerate Fujitsu and office supply retailer Staples Inc., are adding what they call consumer-directed health plans to their menus of insurance options.
In a recent survey, 26% of large employers said they would offer such plans in 2006, up from 14% this year. Another survey found that about half of large companies were considering adding them. …

Over the past sixty years, employers have shifted more compensation to employee health insurance and away from direct income because of an IRS ruling dating from WWII that shields employer-purchased health insurance from income taxes.

Basically, the HMO that your boss pays for is disguised income. Sound good? Or would you rather have more cash in your pocket and lower health insurance premiums?

HSAs encourage consumer responsibility and help employers lower their health care costs. At the same time, unspent income in these accounts can build up an employee nest egg for retirement, and can be used to cover routine health expenses. Employees are still covered for truly catastrophic injuries by traditional insurance, often with lower monthly premiums. Overall, HSAs are a win-win for most employers and employees.

Will HSAs cut down overall health care costs for the small fraction of Americans who are chronically ill? The jury is still out. But the current health care system is now unsustainable—and over-regulated—and HSAs deserves every chance to prove themselves.



Ensuring That All Are Equally Ill
Investor's Business Daily, 5-25-05

Critics of the U.S. health care system point to Europe and Canada’s government-funded programs as cure-alls. But what they don’t notice is that European patients are anxious to escape the straight-jacket of government-rationed health care.

It's not surprising that Europeans are sick of being sick in health care systems that force them to suffer through long waiting periods, bureaucratically determined rationing - as opposed to the self-rationing that would be practiced in a free-market system - and punitively high taxes to pay for the mess. …
Most British patients who need to be seen by a physician for non-urgent care wait 13 weeks, enough time for a nonurgent condition to become quite urgent. A third have to wait more than six months, enough time for a nonurgent condition to turn deadly. …
Some argue that despite these flaws, national health care is effective. But that's not what professor Nick Bosanquet of London's Imperial College thinks. He believes the quality of health of the British system - held out with Canada as the model the U.S. must follow if it's to cure its health care "crisis" - is shabby.
"Our performance on the killer diseases is particularly alarming," he said. "Survival rates for cancer are far higher in the U.S." …


Health Savings Accounts for Seniors
Washington Times, 5-21-05

The Washington Times believes that Medicare’s “financial woes” can be addressed by transitioning seniors into health-savings accounts.

Let recipients have health-savings accounts, let them use Medicare funds to buy high-deductible insurance and then let them put the rest of their Medicare money into HSAs. Allowed to do this, seniors would opt out of the prescription-drug benefit and choose the better coverage that the combination of HSAs and high- deductible insurance can provide. This would save the U.S. Treasury billions annually, not to mention giving seniors greater control over health-care options and cutting inefficiencies. …
To ward off insurers that would "cherry pick" the healthiest seniors…[insurers would not be allowed to adjust] premiums based on a senior's recent medical utilization. Every senior would pay the same amount whether they visit a doctor twice a month or once a year, and insurers would be obligated to take them.


The FDA vs. Cancer Patients
Wall Street Journal, 5-19-05

The Journal takes issue with recent changes at the FDA that indicate that the agency is backing away from “accelerated approvals” for new cancer drugs. (For more detail on these policies, see this week’s Spotlight by Scott Gottlieb.)

The latest evidence of backsliding was a recent vote of the Oncologic Drugs Advisory Committee (ODAC) to recommend against approving Johnson & Johnson's leukemia drug Zarnestra. The drug may not be a miracle cure -- 15% of study patients achieved complete remission. But 15% is nothing to sneeze at either, especially since the company was seeking accelerated approval for the treatment of elderly patients who might not be able to withstand the punishment of traditional chemotherapy. Yet ODAC voted against adding this weapon to the anti-cancer arsenal.
This is a special shame because ODAC used to be a bastion of common sense, wherein clinicians who treat cancer patients would often buck FDA statisticians to approve new drugs. But ODAC is now chaired by osteopath Silvana Martino, who is notably hostile to the drug industry, and so it is unlikely to continue to be an independent check on the FDA.



Statins and the Risk of Colorectal Cancer
New England Journal of Medicine, 5-26-05

Anecdotal evidence—primarily through the retrospective study of patients on statins—continues to suggest they may inhibit the growth of certain cancers.

The Molecular Epidemiology of Colorectal Cancer study is a population-based case–control study of patients who received a diagnosis of colorectal cancer in northern Israel between 1998 and 2004 and controls matched according to age, sex, clinic, and ethnic group. We used a structured interview to determine the use of statins in the two groups and verified self-reported statin use by examining prescription records in a subgroup of patients for whom prescription records were available.
In analyses including 1953 patients with colorectal cancer and 2015 controls, the use of statins for at least five years (vs. the nonuse of statins) was associated with a significantly reduced relative risk of colorectal cancer (odds ratio, 0.50; 95 percent confidence interval, 0.40 to 0.63). This association remained significant after adjustment for the use or nonuse of aspirin or other nonsteroidal antiinflammatory drugs; the presence or absence of physical activity, hypercholesterolemia, and a family history of colorectal cancer; ethnic group; and level of vegetable consumption…

The researchers conclude that statin use “was associated with a 47 percent relative reduction in the risk of colorectal cancer after adjustment for other known risk factors,” and call for further study.


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