WASHINGTON (Reuters) - A gene that affects how the kidneys process salt may help determine a person's risk of high blood pressure, a discovery that could lead to better ways to treat the condition, researchers said on Monday.
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FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs
The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. The documents issued today include the following:
· Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
· Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
· Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.
“The guidance documents reflect the FDA’s continued vigorous efforts to minimize the chances of unsafe products reaching American consumers,” said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.
The Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds discusses the attributes of a third-party certification program that would merit the FDA’s confidence in the quality of the program’s audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA’s future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.
The Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA’s requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA.
The Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. Both draft guidances have a 90-day comment period.
All three guidances support the FDA’s import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. The documents issued today include the following:
· Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
· Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
· Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages.
“The guidance documents reflect the FDA’s continued vigorous efforts to minimize the chances of unsafe products reaching American consumers,” said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.
The Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds discusses the attributes of a third-party certification program that would merit the FDA’s confidence in the quality of the program’s audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA’s future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.
The Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA’s requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA.
The Draft Guidance for Industry on Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. Both draft guidances have a 90-day comment period.
All three guidances support the FDA’s import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
http://health.yahoo.com/news/reuters/us_heart_gene.html 
Key gene linked to high blood pressure identified
By Will Dunham - Mon Dec 29, 11:39 PM PST
A strand of DNA is seen in an undated handout image. (National Institutes of Health/Handout/Reuters)People with a common variant of the gene STK39 tend to have higher blood pressure levels and are more likely to develop full-blown high blood pressure, also called hypertension, University of Maryland School of Medicine researchers found.
They identified the gene's role in high blood pressure susceptibility by analyzing the genes of 542 people in the insular Old Order Amish community in Lancaster County, Pennsylvania.
The researchers confirmed the findings by looking at the genes of another group of Amish people as well as four other groups of white people in the United States and Europe.
About 20 percent of the people studied had either one or two copies of this particular variant, the researchers said.
The gene produces a protein involved in regulating the way the kidneys process salt in the body -- a key factor in determining blood pressure, the researchers said.
Yen-Pei Christy Chang, who led the study appearing in the journal Proceedings of the National Academy of Sciences, said the findings could lead to the development of new high blood pressure drugs targeting the activity of STK39.
"What we hope is that by understanding STK39 we can use that information for personalized medicine, so we can actually predict which hypertensive patients should be on what class of medication and know that they will respond well and have minimal risk for side effects," Chang said in a telephone interview.
People with high blood pressure are more likely to develop heart attacks, heart failure, strokes and kidney disease.
While STK39 may play a pivotal role in some people, Chang said numerous other genes also may be involved. Many factors are involved in high blood pressure such as being overweight, lack of exercise, smoking and too much salt in the diet.
Several different types of medications are used to treat high blood pressure, including diuretics, beta blockers, ACE inhibitors, calcium channel blockers and others. Their effectiveness varies depending on the person, and doctors have a hard time knowing which is best for a particular patient.
Chang said the researchers want to determine how people with different versions of this gene respond to the various drugs and to lifestyle interventions such as cutting the amount of salt in the diet.
The Lancaster Amish are seen as ideal for genetic research because they are a genetically homogenous people whose ancestry can be traced to a small group who arrived from Europe in the 1700s. In addition to genetic similarity, they also maintain similar lifestyles in their close-knit rural communities.
(Editing by Maggie Fox and Vicki Allen)
Adding 30 billion or so to expand SCHIP is a done deal. Now the question is whether there will be any accountability to the families who enroll in the program.
I am not even talking about health outcomes. I am talking about the care actually being there.
As Woody Allen once said: "80 percent of success is showing up." So therefore:
How long will families have to wait to see a doctor for both a sick or well check up?
How long will they have to wait to get referred to a specialist or receive authorization for a procedure or medicine?
Studies show that over time increases in SCHIP enrollment have done nothing to reduce the use of emergency rooms as a routine source of care. Has anyone ever care to ask or find out why? We know that "high ED use in some communities also likely reflects generic preferences for EDs as a source of care for nonurgent problems..." but shouldn't SCHIP be organized in ways to reward less expensive but equally effective sources of care? For further details. see here.
This is not a matter of public vs. private as much it is as trying to make sure the health coverage some how translates into better health. Without a sustained effort the promotes competition based on price, quality and convenience, SCHIP will degenerate into Medicaid for the middle class.
I am not even talking about health outcomes. I am talking about the care actually being there.
As Woody Allen once said: "80 percent of success is showing up." So therefore:
How long will families have to wait to see a doctor for both a sick or well check up?
How long will they have to wait to get referred to a specialist or receive authorization for a procedure or medicine?
Studies show that over time increases in SCHIP enrollment have done nothing to reduce the use of emergency rooms as a routine source of care. Has anyone ever care to ask or find out why? We know that "high ED use in some communities also likely reflects generic preferences for EDs as a source of care for nonurgent problems..." but shouldn't SCHIP be organized in ways to reward less expensive but equally effective sources of care? For further details. see here.
This is not a matter of public vs. private as much it is as trying to make sure the health coverage some how translates into better health. Without a sustained effort the promotes competition based on price, quality and convenience, SCHIP will degenerate into Medicaid for the middle class.
According to a story in today’s
Personalized medicine is not about denying care. It’s about providing “the four rights” (the right medicine in the right dose to the right patient at the right time). Personalized medicine can (indeed must!) be both cost-effective and patient-centric.
Yet, on the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial. For more on this issue see "Diagnostical Materialism.”
Diagnostics reimbursement should be based on value rather than activity.
On the regulatory front greater clarity and predictability are required. At present, FDA guidance on diagnostic approvals are vague. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
The Critical Path Institute (created in 2005 by the
According to a recent article in the Journal of Life Sciences,
“The United States Diagnostic Standards will offer a voluntary certification for laboratory and pathology diagnostics, much like the Underwriters Laboratories certification for many tools and equipment. Companies already submit their tests to data test sites for evaluation prior to FDA submission, says Jeffrey Cossman, chief scientific officer of C-Path. This would take the place of a data test site.”
This speaks directly to the contentious issue of partnership between the FDA, industry and academia. No one entity can do it alone. This is a core philosophy that will, no doubt be vigorously debated in Congress – and by the next FDA commissioner. We need a stated policy of pragmatic partnerships.
Nobody said it going to be easy.
Relative to FDA oversight of clinical trial investigator conflict of interest, the New York Time opines:
Absolutely. Transparency. Transparency. Transparency. The agency's lack of funding (and ensuing lack of manpower to accomplish the task in a thorough and timely manner) must be remedied. Editorializing about the problem is important -- doing so about the solution, even more so. Want the problem fixed? Show me the money! Otherwise it's just rhetoric.
The Times continues:
Not so fast. Beyond the obvious fact that such a database would help nobody other than trial lawyers, a more dire unintended consequence would be the unfair stigmatization of doctors and scientists who participate in clinical trials sponsored by pharmaceutical companies. Fearful of jeopardizing their reputations, this could motivate many to leave clinical trial research altogether -- making trials more difficult tand more expensive to field in the first place. And this outcome is most definitely not in the best interests of the public health.
Let's do the right thing -- but not get carried away.
The full Times editorial can be found here.
Enraging the enemies of medical progress everywhere, the FDA finished up a decade long progress of issuing regulations about how companies can provide information about the off-label use of medical products. Of course the media, including those who do puff pieces on Sid Wolfe, will portray off-label use as inherently dangerous. But to the extent that most off-label uses wind up become standard therapy and to the extent that off-label applications are used a benchmarks in the evaluation of drug safety and efficacy of new drugs in advisory committees, often by the same critics of off-label use to block new drugs, how dangerous is off-label use? And at a time when such use can be monitored, compared and evaluated at a patient level and is often essential because of genetic variation, I want to see who will propose making off-label use illegal. Maybe a study that looks at the number of lives saved and improved through off-label use is in order.
No real surprise that Frank Torti was named Acting FDA Commissioner. After all, as the Principal Deputy to the Commish, it makes both logical and bureaucratic sense. Facts and precedent notwithstanding, the usual suspects are trying very hard to make the case that this is a deliberate slight to Janet Woodcock. Balderdash.
What the Torti appointment does demonstrate (IMHO) is a vote of confidence on the part of the incoming administration in the agency's career staff -- and a polite "mind your business" to certain members of Congress. After all, it was only last month that Representative Bart Stupak wrote to President-elect Obama recommending, " ... not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA."
Thanks Bart. But no thanks.
What the Torti appointment does demonstrate (IMHO) is a vote of confidence on the part of the incoming administration in the agency's career staff -- and a polite "mind your business" to certain members of Congress. After all, it was only last month that Representative Bart Stupak wrote to President-elect Obama recommending, " ... not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA."
Thanks Bart. But no thanks.
Thomas Sowell, intellectual giant and senior fellow at the Hoover Institution, recently wrote a glowing review of Sally C. Pipes’ new book "The Top Ten Myths of American Health Care."
Sowell offers this profound insight about the state of the current healthcare discussion in the country:
It is one of the painful signs of our times that millions of people are so easily swayed by rhetoric that they show virtually no interest at all in finding out the hard facts. Any number of other countries already have government-controlled medical professions. Yet few Americans show any interest in what actually happens to medical care in those countries.
Instead, we are being lured into a one-way process-- much like entering a Venus fly trap-- by the oldest of all confidence rackets, the promise of something for nothing.
Sowell continues:
The lure of something for nothing may be seductive when you are in good health. But it can become a bitter irony when you are waiting for months for surgery to relieve your pain or when your life hangs in the balance while some bureaucrat decides whether you can get the best medication or something older and cheaper.
A bitter irony indeed. Remember those words: The promise of something for nothing. These words define the 'universal healthcare' movement.
The lofty promises from "Universal Healthcare" advocates undoubtedly have great appeal to many Americans. That is why in the coming months it is vital that those of us who value a patient-centered, free-market healthcare system step up efforts to effectively counter the false promises being peddled by advocates of government-run healthcare.
Economist Robert Samuelson has a superb piece in Newsweek dispelling some of the common myths perpetuated by single-payer health-care supporters.
Here are a few particularly noteworthy excerpts.
On administrative overhead:
One is that our mixed private-public insurance system drives up costs through high administrative overhead. Claim forms create a paperwork morass; marketing expenses add to the burden. True, overhead costs in the United States are more than double the level in other countries. But the effect is modest, because all administrative costs account for a mere 7 percent of total health costs. Even halving administrative costs would offset only about six months of the annual growth in health spending of 6 to 7 percent.
On the supposed superiority of Universal health care systems:
What really drives health spending, the study finds, is that Americans receive more costly medical services than other peoples do, and pay more for them. On a population-adjusted basis, the number of CT scans in 2005 was 72 percent higher in the United States than in Germany; U.S. reimbursement rates were four times higher. Knee replacements were 90 percent more frequent than in the average wealthy country and are growing rapidly. In 2005, there were 750,000 knee and hip replacements, up 70 percent in five years, reports the journal Health Affairs.
On American values and free-market healthcare:
We have a health-care system that reflects our national values. It's highly individualistic, entrepreneurial and suspicious of centralized supervision. Despite gripes about limits imposed by private insurers and Medicare, there are few effective controls on doctors' and patients' choices. That's what most Americans want. Patients understandably desire the most advanced surgeries, diagnostic tests and drugs. Doctors want the freedom to prescribe and recommend.
The FDA has finalized guidelines that govern off-label information sharing.
The FDA document states that doctors should be made aware of experimental uses for drugs and devices -- even if regulators have not approved them.
"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency.
Knowledge is power. And information saves lives.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
