Health News and Scoops

In response to confirmed cases of swine flu in Mexico, Canada, and the United States, European Union health officials are advising against travel to North America. At airports in Japan and several other Asian countries, thermal scanners are being used to identify fever among passengers from North America.

But in the U.S. the disease is already among us. The severity and extent are unknown. The SARS outbreak (severe acute respiratory syndrome) in 2003 teaches that rigorous infection control in hospitals may be key to limiting deaths from swine flu in the U.S. Much will depend on what hospitals do when the first seriously ill victims arrive.” If hospitals have effective infection controls in place, the disease can be prevented from spreading to visitors, healthcare workers and their families,” warns Betsy McCaughey, Ph.D., and Chairman of the Committee to Reduce Infection Deaths (RID), a national organization that educates the public and medical community about preventing infection. McCaughey explains that “77% of the people who contracted SARS in the Canadian outbreak were patients, visitors or workers in hospitals. SARS was almost entirely a hospital infection epidemic.”

SARS — four letters that filled the headlines in the spring of 2003, and then disappeared. “A report issued after the fact by the government of Ontario (The SARS Commission, Spring of Fear, December 2006) shows how hospitals in one city thwarted an epidemic while hospitals in another city made deadly mistakes” says McCaughey, an expert on preventing infection.

Many hospitals in the U.S. are under-prepared for a similar challenge. As many as ten percent of patients contract infections in the hospital, according to the Centers for Disease Control and Prevention. Bacteria such as MRSA (methicillin-resistant Staphylococcus aureus) and Clostridium difficile race through hospitals, spread by unwashed hands and unclean equipment. How can hospitals that are failing to prevent ordinary infections spread by touch contain a new, unknown virus that can spread whenever someone coughs or sneezes?

“The best defense against swine flu and other unknown pathogens is rigorous hospital hygiene and routine infection prevention. That is the lesson of SARS,” says McCaughey.

Dr. McCaughey is available to speak about the precautions that should be taken in hospitals, schools, day care centers, nursing homes and other places where the disease can spread easily.

Betsy McCaughey, Ph.D., is founder of the Committee to Reduce Infection Deaths and former Lt. Governor of New York State.

Source

Medication mistakes at home have created a dangerous situation in America according to a recent national study, and the need for a new approach to medication management is critical, according to Shane Reeves, D. Pharm and co-owner of Reeves-Sain.

Reeves said we need to move away from the traditional system of bottles to a clearer, more easily managed system, and his company has developed the product to do that.

The Reeves-Sain product, called MediPACK, pre-packages a consumer’s medications in easy to manage, easy to carry plastic packs with a day’s total medication included in one package. The system eliminates error because the individual packages contain only the prescribed medications for that day. The information on the outside of the package details the medications included, when they are to be taken and what day they are scheduled for.

The information is scary, says Reeves. Speaking to the Fearless Caregiver conference in Nashville last month, he said, “The fact that deaths have risen dramatically in this relatively short period is evidence that the medication management system has changed. More dosage management of a wider range of drugs, including painkillers, is now in the hands of the patient, many of whom are older and less able to manage a large number of medications.”

The findings, based on nearly 50 million U.S. death certificates, were published earlier this year by the Archives of Internal Medicine. Deaths from medication mistakes at home increased from 1,132 deaths in 1983 to 12,426 in 2004. Adjusted for population growth, that amounts to an increase of more than 700 percent during that time. The increase in deaths was highest among baby boomers, people in their 40s and 50s.

“The amount of medical supervision is going down, and the amount of responsibility put on the patient’s shoulders is going up,” said lead author David Phillips of the University of California-San Diego.

People share prescriptions at an alarming rate, said boomer Dr. J. Lyle Bootman, the University of Arizona’s pharmacy dean, who was not involved in the research. One recent study found 23 percent of people say they have loaned their prescription medicine to someone else and 27 percent say they have borrowed someone else’s prescription drugs.

Reeves-Sain’s MediPACK system has been available in nursing homes and assisted living centers through Reeves-Sain’s extended care division, but the company saw an opportunity to extend it for general use. Because the medications are pre-packaged they can be ordered anywhere and Reeves-Sain handles delivery.

Reeves-Sain, founded in 1980 and locally owned throughout its existence, is a comprehensive medical operation, providing everything from medical equipment, pharmaceuticals, diabetes and oxygen services and a range of other programs such as an in-store soda shoppe. The company also operates a pharmacy-only service in the Murfreesboro Medical Clinic.

Press

By Amy Norton

NEW YORK |
Fri Jul 29, 2011 4:21pm EDT

NEW YORK (Reuters Health) – Women who screen positive for gene mutations that promote breast and ovarian cancers usually opt for surgery to cut their risk of the diseases, a new study suggests.

The research, reported in the journal Cancer, followed 465 women who were tested for mutations in the genes BRCA1 and BRCA2 that substantially boost the lifetime risks of breast and ovarian cancers.

It found that more than 80 percent of women who tested positive for the harmful mutations ultimately chose to have surgery to remove their ovaries, breasts or both.

“Almost all of the women who screened positive did take some sort of action,” said lead researcher Dr. Marc D. Schwartz, of the Lombardi Comprehensive Cancer Center in Washington, D.C.

That may not seem surprising. But Schwartz said there has been some skepticism about how many women with BRCA mutations would choose to have their ovaries or breasts removed.

“It’s a difficult decision to have prophylactic (preventive) surgery,” Schwartz noted in an interview.

“There’s been a perception that risk-reducing surgery, especially risk-reducing mastectomy, was not something most mutation carriers would choose,” he said.

But most studies on the issue, at least in the U.S., have been short-term — looking at women’s choices in the year or so after a BRCA test result. Women in the current study were followed for an average of just over five years.

Defects in the BRCA1 and BRCA2 genes substantially raise a woman’s lifetime risks of breast and ovarian cancers — to a roughly 60 percent chance of developing breast cancer, and a 15 to 40 percent risk of ovarian cancer.

By comparison, the average U.S. woman has a 12 percent chance of developing breast cancer during her lifetime and only a 1.4 percent chance of ovarian cancer.

Because of the high risks, experts recommend that some women with a strong family history of breast or ovarian cancers be screened for the gene mutations.

For women who test positive, it’s a “pretty firm recommendation” that they have their ovaries removed by about age 40, Schwartz said.

That’s because ovarian cancer is difficult to catch early and, therefore, has a high death rate. And studies have found that when a woman has a BRCA mutation, surgery to remove the ovaries not only slashes her risk of developing the cancer by about 90 percent, but can also extend her life.

The recommendations on preventive mastectomy are less firm, Schwartz said.

The surgery does cut carriers’ risk of breast cancer by roughly 90 percent. But removing just the ovaries is effective as well — cutting a mutation carrier’s breast cancer risk in half, because removing the ovaries takes away the body’s main source of estrogen.

And unlike ovarian cancer, breast cancer can often be detected early: For women with BRCA mutations who choose not to have a mastectomy, experts recommend regular screening with not only mammography, but also MRI scans, which are better at spotting breast tumors in their earliest stages.

Of the 465 women tested in the current study, 31 percent were found to carry BRCA mutations.

There were 100 mutation carriers who still had their ovaries, and two-thirds ultimately opted to have their ovaries and fallopian tubes removed.

And of 108 mutation carriers who still had at least one breast, 37 percent chose to have a mastectomy.

(Most of the women in the study had already been diagnosed with breast or ovarian cancer when they decided to have BRCA testing, so some had previously had one breast or their ovaries removed.)

The U.S. Preventive Services Task Force, an expert panel supported by the federal government, recommends that women with certain family-history patterns of breast or ovarian cancers consider BRCA testing.

That includes women who’ve had: two first-degree relatives (mother, sister or daughter) diagnosed with breast cancer, one of whom developed the disease by age 50; three or more first- or second-degree relatives diagnosed with breast cancer at any age; two or more first- or second-degree relatives with ovarian cancer. The full task force recommendation can be viewed here: bit.ly/p2aiWD.

About 2 percent of U.S. women would meet the criteria for considering BRCA testing, according to the USPSTF.

According to Schwartz, the current findings “lend credence” to the belief that BRCA testing will ultimately make a difference in carriers’ risk of developing breast and ovarian cancers, and possibly extend their lives.

The primary limitation of the study, he said, is that all of the women were tested and received genetic counseling at a single medical center. “Out in the world, the results may be different,” Schwartz said.

Individual doctors can, and increasingly are, ordering BRCA testing. And women may or may not get the genetic counseling that’s recommended for helping them decide what to do with the test result.

And that result is often not straightforward. Many women get what’s called an “inconclusive” or “uninformative” result: They do not have a known BRCA mutation, but the possibility that they have some genetic abnormality cannot be ruled out.

That’s in contrast to a “true negative” BRCA result — where a woman tests negative for mutations that had previously been found in a family member.

For women with an inconclusive result, Schwartz said, genetic counseling can help them decide what to do.

If their family history of breast or ovarian cancers is very strong, it might be assumed that there is some sort of genetic risk. So they might still consider preventive surgery or possibly regular MRI screening for breast cancer.

SOURCE: bit.ly/kQfXNS Cancer, online June 29, 2011.

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By Andrew Seaman

WASHINGTON |
Fri Jul 29, 2011 5:56pm EDT

WASHINGTON (Reuters) – An advisory group said the U.S. fast-track approval process for medical devices is fatally flawed and should be replaced, but the Food and Drug Administration said the recommendation was a non-starter.

The FDA had asked for the Institute of Medicine report as part of a broad agency review of its device unit, an area dogged by high staff turnover, funding woes and major recalls in recent year of devices ranging from artificial hips to heart defibrillators.

The IOM found the fast-track approval process, called 510(k), does not adequately protect patients and recommended a more thorough approval process likely to raise the costs for device makers with pre-market and post-market device reviews.

“What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device,” said Dr. David Challoner, chairman of the IOM’s committee.

But the finding was swiftly rejected by the FDA’s top device official.

“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The 510(k) program allows medical devices to get to market faster if they are “substantially equivalent” to an existing product.

Critics say the accelerated 510(k) process is too widely used and leads to inadequate testing for some risky devices, but it is defended by the industry as necessary to speed technologies to patients.

The medical device industry has argued for either leaving the 510(k) process as it is or further streamlining the approval process. Most new medical devices — about 4,000 in 2009 — are cleared through the accelerated program.

The FDA has proposed changes, including the possibility of creating a new category of more risky devices that would require more data to win approval.

But the IOM committee said the FDA should not waste its limited resources on changing the current program. Instead, the committee said the FDA should focus on developing a new framework.

High-profile incidents include a massive recall last year of artificial hips by Johnson Johnson’s DePuy unit. Some 93,000 patients worldwide had that line of hip implant.

Automated external defibrillators, used in public places such as airports to revive cardiac arrest victims, have also made up a significant portion of 510(k) recalls in recent years. Health officials are looking at thousands of reports of malfunctions which may have led to patient harm or death.

Medical devices range from simple bandages to complex implants such as pacemakers, stents and artificial knees. Other than Johnson Johnson, the largest medical-device makers include Medtronic Inc, Boston Scientific Corp and Abbott Laboratories Inc.

The IOM suggested the FDA start collecting information to build the new process, including post-market data for devices. Congress should then enact legislation to design the regulatory framework, according to the report.

“A new system needs to be put in place that will be more effective especially in post-market surveillance,” said Challoner.

(Reporting by Andrew Seaman; Additional reporting by Alina Selyukh; Editing by Tim Dobbyn)

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By Andrew Seaman

WASHINGTON |
Fri Jul 29, 2011 4:36pm EDT

WASHINGTON (Reuters) – An advisory group said the U.S. fast-track approval process for medical devices is fatally flawed and should be replaced, but the Food and Drug Administration said the recommendation was a non-starter.

The FDA had asked for the Institute of Medicine report as part of a broad agency review of its device unit, an area dogged by high staff turnover, funding woes and major recalls in recent years of devices ranging from artificial hips to heart defibrillators.

The IOM found the fast-track approval process, called 510(k), does not adequately protect patients and recommended a more thorough process that would likely to raise the costs for device makers with pre-market and post-market device reviews.

“What we are recommending is that the 510(k) is fatally flawed in terms of it not evaluating safety and effectiveness of a device,” said Dr. David Challoner, chairman of the IOM’s committee.

But the finding was swiftly rejected by the FDA’s top device official.

“FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Wall Street analysts said the report was not a game-changer, at least in the near term. Legislation would be required for any significant changes to the device approval process.

“The 510(k) process was established in 1976 and it was meant to be a temporary stop-gap,” said Thomas Gunderson, an analyst with Piper Jaffray. “The process can certainly be improved upon, but at the current pace, I don’t see this (IOM report) having any meaningful impact.”

Senator Al Franken said the IOM was advocating new burdens for the medical device industry without a clear path to a more effective process.

“Calling for the elimination of the 510(k) process could be very harmful to innovation,” said Franken, a member of the Senate’s health committee and whose state of Minnesota is home to Medtronic Inc, a major device maker.

The 510(k) program allows medical devices to get to market faster if they are “substantially equivalent” to an existing product.

Critics say the accelerated 510(k) process is too widely used and leads to inadequate testing for some risky devices, but it is defended by the industry as necessary to speed technologies to patients.

The medical device industry has argued for either leaving the 510(k) process as it is or further streamlining the approval process. Most new medical devices — about 4,000 in 2009 — are cleared through the accelerated program.

IOM’s Challoner said in a briefing on Friday that he recognizes the report is suggesting “a paradigm shift” that could be disquieting to the medical device industry, consumers and regulators.

Another IOM committee member, however, said the current 510(k) system “has been reasonably safe.”

“We do not believe that one has to shut down the system tonight. We think it is working adequately in the short term,” said William Vodra.

The industry group Advanced Medical Technology Association, or AdvaMed, said Congress and the FDA should not seriously consider the report’s conclusions.

“(The report) proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure,” AdvaMed’s CEO and president Stephen Ubl said. “This would be a disservice to patients and the public health.”

Medical devices range from simple bandages to complex implants such as pacemakers, stents and artificial knees. Other than Johnson Johnson, the largest medical-device makers include Medtronic, Boston Scientific Corp and Abbott Laboratories Inc.

High-profile incidents include a massive recall last year of artificial hips by Johnson Johnson’s DePuy unit.

Some 93,000 patients worldwide had that line of hip implant.

Automated external defibrillators, used in public places such as airports to revive cardiac arrest victims, have also made up a significant portion of 510(k) recalls in recent years. Health officials are looking at thousands of reports of malfunctions which may have led to patient harm or death.

(Reporting by Andrew Seaman; Additional reporting by Alina Selyukh and Debra Sherman; Editing by Tim Dobbyn)

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