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Congress undermines public trust by overriding mammography guidelines, authors say

Last December, Congress slipped into its $1.15 trillion spending bill a measure that “undermines women’s rights to make informed decisions based on the best scientific evidence,” according to a commentary published recently in the Journal of the American Medical Association (JAMA).

That measure requires health insurers to follow the U.S. Preventative Services Task Force’s (USPSTF) breast cancer screening guidelines from 2002 rather than the task force’s two more recent ones, including its latest, which was issued just a few weeks ago.

The 2002 USPSTF guidelines recommended that average-risk women undergo mammography screening every one to two years beginning at age 40. After an exhaustive examination of the most recent scientific evidence, the task force updated their guidelines in 2009 and again this year to recommend that biannual screenings start later, at age 50.

“Essentially, Congress is requiring health insurers to ignore modern scientific assessments and instead use 14-year-old guidance,” write Dr. Kenneth Lin, a family medicine physician at Georgetown University, and Lawrence Gostin, a law professor at the same institution, in the JAMA commentary.

That action has important ramifications that go beyond the issue of breast cancer screening, they add, for it also weakens the public’s trust in the value of evidence-based science.

Political backlash

Some background: One of the requirements of the Affordable Care Act (ACA), which was passed by Congress late in 2009 and was signed into law by President Barack Obama in 2010, is that private insurance plans must provide “first-dollar” coverage (no co-payments, coinsurance or deductibles) for any preventive service that receives an “A” or “B” grade from the USPSTF. (Those grades mean there’s a “high certainty” that the service’s net benefit for patients is “moderate” or “substantial.”)

Created in 1984, the USPSTF is an independent panel of experts with backgrounds in prevention and evidence-based medicine. They volunteer to assess the best evidence on various preventive services, and then make clinical recommendations regarding those services. Those recommendations are published in peer-reviewed journals (and on the USPSTF’s website), and are periodically updated.

In 2009, the USPSTF gave only a C grade to mammography screening for women aged 40 to 49 who are at average risk of developing breast cancer. This recommendation caused an instant and sometimes vicious backlash from medical groups, such as the American College of Radiology and the Medical Imaging and Technology Alliance, as well as from a few women’s health organizations.

The USPSTF’s updated guidelines were widely (and angrily) misinterpreted, however. Many people believed the task force was saying that women under the age of 50 should be denied access to mammography screening.

“A C grade is commonly misunderstood,” explain Lin and Gostlin. “It does not advise against screening, but rather it indicates moderate certainty that there is small population-level benefit. Clinicians should discuss C-rated services with patients using an individualized assessment of the patients’ risk factors and preference.”

And although insurers do not have to offer “first-dollar” coverage for a C-graded service, that was never really going to be the case with mammography.

As Lin and Gostlin point out, “Importantly, irrespective of USPSTF recommendations, most insurers have offered mammography coverage for women aged 40 through 49 years.”

Wrongly framed

One reason for all the controversy was that the USPSTF guidelines were framed by critics as a form of health-care rationing.

“Yet the Task Force uses a rigorous scientific methodology focusing on net health benefits and does not take economic cost into account,” the two Georgetown professors explain.

Furthermore, the USPSTF is not alone in its interpretation of the evidence regarding mammography screening.  In Great Britain, for example, the National Health Service currently recommends that average-risk women be screened every three years starting at age 50 . And late last year, the American Cancer Society, shifted its recommended starting date for routine mammography from 40 to 45

“By declining to acknowledge scientific progress, Congress may do more harm than good to women’s health,” write Lin and Gostin. 

There is also a real risk, they add, that Congress may soon begin to erode the Task Force’s independence.

“The House’s version of 2016 omnibus spending bill (which was not included in the final legislation) would have denied funding for any future USPSTF mammography recommendation,” they explain. “Some members of Congress have gone further, proposing to alter the Task Force’s composition to include ‘stakeholders from the medical products manufacturing community.’”

Political second-guessing

So far, the USPSTF has withstood the pressures on its independence and scientific integrity, but will they be able to continue doing so in the future? 

Yes — if the public demands that Congress stop second-guessing the task force’s independent experts.

“When Congress required [the government] to link insurance coverage policy to outdated public health guidance, it was making a scientific judgment for which it is distinctly unqualified,” write Lin and Gostlin. “In effect, legislators implicity concluded that a rigorous assessment of numerous research studies during the past 14 years is not relevant to women’s health today.”

“Congress’s paternalistic response to USPSTF mammography screening recommendations vividly illuminates the social costs of politically mandated care,” they add. “Rather than benefiting women, political interference with science can discourage shared decision making, increase harms from screening, and foster public doubt about the value and integrity of science.”

FMI:  The commentary was published online in JAMA on Jan. 18, where it can be read in full.

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Cancer drugs are often approved without evidence that they extend life, reporters find

On Sunday, the Milwaukee Journal Sentinel and MedPage Today published the latest installment in their wonderful “Slippery Slope” investigative series on the dubious practice of approving new drugs based on “surrogate measures” rather than on actual health outcomes.

This latest article focuses on the cancer drug Afinitor (everolimus), which the U.S. Food and Drug Administration (FDA) has approved for the treatment of breast cancer, kidney cancer, a rare type of pancreatic cancer and two types of nonmalignant tumors.

As Journal Sentinel reporter John Fauber and MedPage Today reporter Coulter Jones point out, Afinitor has been shown to delay the growth, or progression, of tumors by a few months, but it has not been shown to help people live longer.

Write Fauber and Jones:

In 2012, the FDA approved Afinitor for a common type of advanced breast cancer known as hormone receptor-positive, HER2 negative. Of all the conditions [for which Afinitor has been approved], it has the biggest potential pool of patients. That type is found in up to 70% of breast cancers.

The FDA approval was based on a clinical trial using Afinitor in tandem with exemestane, another breast cancer drug, vs. a placebo and exemestane.

The trial, which involved women who had failed one of two other drugs, showed the Afinitor combination offered progression-free survival of eight months, compared with three months in those who got the placebo and the other drug alone.

But it was not shown to extend survival.

Serious side effects

Nor have clinical trials found any evidence that Afinitor improves patients’ quality of life. In fact, the drug produces some serious and debilitating side effects, including mouth sores, infections, fatigue, diarrhea, abdominal pain, fever, cough, headache and decreased appetite.

Write Fauber and Jones:

In the [clinical] trial for advanced breast cancer, 63% of those taking Afinitor had to cut the dose of the drug or temporarily stop treatment, compared with 14% who got a placebo. Some 24% had to stop using it altogether, compared with 5% who got a placebo. 

And nearly one in five developed a potentially fatal lung condition known as noninfectious pneumonitis. …

Since 2009, the year the drug first got on the market, there have been nearly 9,000 reports of serious adverse reactions among Afinitor users, including more than 2,700 deaths and more than 3,100 hospitalizations.

A broader problem

Last year, Fauber and Jones reported that 74 percent of new cancer drugs approved by the FDA over the past decade had not been shown to actually extend or improve life, only to slow the growth of tumors.

A study published this past October in JAMA Internal Medicine made a similar finding. It reported that 67 percent of cancer drugs approved during a recent five-year period (2008-2012) received that approval based solely on surrogate measures of effectiveness. 

“Our results suggest that the FDA may be approving many costly, toxic drugs that do not improve overall survival,” the authors of the study wrote.

And these are very expensive drugs. The price tag for Afinitor alone can be as high as $11,400 a month — a figure that has jumped $3,000 a month since 2014, Fauber and Jones report.

But the problem is much broader than cancer drugs. Previous Journal Sentinel/MedPage investigations have found that the FDA’s reliance on surrogate measures “has led to a steady stream of costly drugs of dubious value over the past decade — not just in cancer, but for conditions such as diabetes, low testosterone and obesity.”

Conflicts of interest

Fauber and Jones also point out that the studies the FDA relies on when approving new drugs often have a high potential for bias:

A Journal Sentinel/MedPage Today analysis found at least 10 published papers — all funded by Novartis [the maker of Afinitor] and written mostly by experts with financial ties to the company — that played up the benefits of the drug for breast cancer patients, such as touting progression-free survival.

Two-thirds of the 64 co-authors listed on the papers were doctors and other experts with financial conflicts of interest. This included individuals who were consultants, speakers, advisers or even employees of Novartis. 

For instance, a 2013 paper funded by the company concluded that Afinitor did not negatively affect quality of life in breast cancer patients. Twelve of the 20 authors were consultants, speakers or employees of the company.

A year earlier, reviewers at the FDA came to a different conclusion, saying there was no proven quality of life benefit for the drug and noted there was a large portion of quality of life data missing from the clinical trial.

More to come?

Novartis told Fauber and Jones that it follows strict guidelines to ensure that its studies are bias-free. The company also pointed out to the reporters that Afinitor has been approved for use in more than 100 countries.

The company is also hoping that the FDA will soon approve Afinitor’s use for three more medical conditions.

You can read Fauber and Jones’ investigative report on Afinitor on either the Milwaukee Journal Sentinel or the MedPage Today websites.

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