Bayer Aspirin With Supplements Is Illegal, U.S. Warns

Bayer Aspirin With Supplements Is Illegal, U.S. Warns
By Justin Blum

Oct. 28 (Bloomberg) — Pills made by Bayer AG that combine aspirin with dietary supplements to fight osteoporosis and high cholesterol are being sold illegally and could harm consumers, U.S. regulators said.

The non-prescription products are Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, which contains plant-based substances called phytosterols, the Food and Drug Administration said in a statement today. The agency has also sent warning letters to the company.

Dietary supplements generally don’t need FDA approval. The agency is responsible, though, for approving new drugs and has in the past warned companies they need clearance to sell products that combine the two. The regulators focused on the Heart Advantage product after it was introduced this year.

“The marketing of these unapproved drugs is troubling,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “The overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events.”

The FDA isn’t aware of harmful side effects from the products, the agency said in its statement.

Bayer, of Leverkusen, Germany, gained 63 cents, or 1.6 percent, to 38.52 euros at 1:52 p.m. New York time today in Frankfurt trading. The shares have lost 38 percent of their value this year, compared with a 13 percent decline in the Bloomberg Europe Pharmaceutical Index.

Bayer’s Response

Bayer “stands behind the marketing of both products,” said Anne Coiley, a Bayer spokeswoman, in a telephone interview. The products contain language telling consumers to consult with their doctors, she said. The company will review the warning letters and respond to the FDA, she said.

The FDA said the products’ combination of aspirin and the supplements — along with their beneficial health claims — cause them to be classified as new drugs, requiring agency approval.

The FDA began examining Heart Advantage after it was introduced earlier this year, said Michael Levy, acting assistant director of compliance in the FDA’s drug division. The agency was especially concerned about that product because “it is a combination that we have not seen before,” Levy said in a telephone interview.

Other Product Review

The FDA also decided to examine the women’s aspirin, introduced in 2002, “in the interest of consistency,” he said.

The calcium in the women’s aspirin is intended to help against osteoporosis, a bone-thinning disease, while the phytosterols are intended to lower the bad form of cholesterol.

Aspirin can be combined with calcium for use in buffered aspirin, according to the agency. When combined to make an aspirin product that claims to fight osteoporosis, the product becomes a new drug that needs FDA approval, according to the agency.

Companies that don’t resolve FDA violations raised in warning letters risk sanctions such as injunctions or seizures, according to the FDA.

Two House Democrats — Representatives John Dingell and Bart Stupak of Michigan — wrote to the Health and Human Services Department, which oversees the FDA, on Oct. 14 questioning whether the Heart Advantage product violates agency rules. They cited a May 2000 letter from the FDA saying that the agency recommends that companies refrain from marketing products that combine drugs and dietary supplements.

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FDA’s conclusion that chemical is safe is flawed

WASHINGTON – An independent panel of science advisers is taking issue with the FDA’s assessment that a controversial chemical is safe.

In a report to the agency, the panel concluded: “The margins of safety identified by FDA as ‘adequate’ are, in fact, inadequate.”

The chemical, known as bisphenolA, is used to make plastic baby bottles and sealants for cans that contain food. Environmental groups are seeking to have it banned in products for young children.

The advisers found that the FDA had not considered all the scientific evidence available in concluding that BPA is safe.

oct/2008

AMERICAN HOME PRODUCTS CORP. et al. v. FERRARI et al

Supreme Court of Georgia

Decided: October 6, 2008

AMERICAN HOME PRODUCTS CORP. et al. v. FERRARI et al

 

Summary

AMERICAN HOME PRODUCTS CORP. ET AL. V. FERRARI ET AL. (S07G1708)

 

 
Attorneys for Appellants (Manufacturers): Lowell Fine, Leslie Suson, Robert Hays, Matthew Harman
Attorney for Appellees (Ferraris): Lanny Bridgers

 

The state Supreme Court has upheld a decision by the Georgia Court of Appeals and ruled in favor of a Fulton County couple who sued several vaccine manufacturers for damage done to their toddler by childhood vaccinations. In today‟s landmark decision, written by Justice George Carley , the high court has unanimously affirmed the Court of Appeals judgment, which was the first appeals court in the nation to decide that the 1986 National Childhood Vaccine Injury Compensation Act does not preempt state law permitting such lawsuits. At issue is the language of the federal law, which states that vaccine manufacturers cannot be held liable for vaccine-related injuries or deaths “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The case was brought by Marcelo and Carolyn Ferrari, after they took their son Stefan, born in 1998, to get his early childhood vaccinations. Prior to being vaccinated, his parents claim, Stefan was a healthy verbal toddler. Subsequently, he stopped speaking and has not spoken since. The Ferraris sued several vaccine manufacturers, including American Home Products Corp., alleging that their son suffered neurological damage caused by vaccines containing thimerosal, a mercury-based preservative. The trial court ruled in favor of the vaccine manufacturers, ruling that the Ferraris‟ design defect claims were preempted by the national Vaccine Act. The Court of Appeals, however, reversed the decision and ruled in the Ferraris‟ favor, calling the federal law unclear and capable of being read two different ways. 2 In reaching today‟s decision, the Supreme Court has carefully reviewed the law and congressional intent in determining that the Vaccine Act “clearly does not preempt all design defect claims against vaccine manufacturers.” Rather the law only protects the manufacturers from liability if it is determined, on a case by case basis, that the vaccine‟s side effects were unavoidable. In this case, the Ferraris argued that their son‟s injuries could have been avoided if the manufacturers had not used thimerosol in their vaccines. Even if the language of the federal law is ambiguous, today‟s 19-page opinion says, “the legislative history hardly shows a „clear and manifest‟ congressional purpose to supplant state tort law with respect to claims of defective design.

Attorneys for Appellants (Manufacturers): Lowell Fine, Leslie Suson, Robert Hays, Matthew Harman

Attorney for Appellees (Ferraris): Lanny Bridgers

 

 

 

 

 

Is Science What You Think it is?

Is Science What You Think it is?

 

 

What is Science? According to Wikipedia it is defined as:

 

Science (from the Latin scientia, meaning “knowledge” or “knowing”) is the effort to discover, and increase human understanding of how the physical world works. Through controlled methods, scientists use observable physical evidence of natural phenomena to collect data, and analyze this information to explain what and how things work. Such methods include experimentation that tries to simulate natural phenomena under controlled conditions and thought experiments. Knowledge in science is gained through research.

 

Science is ultimately about discovery and discovering ‘new’ laws of nature that have existed since the beginning of time.  Science gets its foundation from mathematics as it provides the methods to compose, correlate, model, analyze, and predict. Statistics, on the other hand, is something that can be misused due to suppression of data, misinterpretation of data, poorly designed experiments, and passing off fiction as fact. Science relies on experiments which have to be reproducible. Experiments should be large (population size, racial, economical, and social for instance) and double blind. Only the product(s) you wish to test should be in the experiment to be truly ‘double blind’. The placebo effect must also be taken into consideration.

 

 

 

Real Science should begin with no conclusions because the scientist is searching for truth and they don’t know what that truth is yet. They would do this by forming a hypothesis, make predictions for the hypothesis, and then test the predictions. The research would then reject or revise the hypothesis. Real science will point out flaws in their research, while junk science pretends there is none. Is raw data really ‘raw’? No, because it is what you planned from the start. The whole experiment from the theory, structure, system, what you believe, what you test, and how you test, etc. will be based on preconceptions. Truth will become what the structure says it is from the very start. The hypothesis will control what science does and will control all the details. So is it truly 100% objective? A hypothesis can be strong, and the belief held that it is correct, which could make things be seen that are not truly there. Some investigations and research end up being left ‘unfinished’ if it looks like the results contradict an accepted view or don’t meet the expected hypothesis.

 

TEN MYTHS OF SCIENCE: REEXAMINING WHAT WE THINK WE KNOW…
(McComas, William, Ten myths of science: Reexamining what we think we know…., Vol. 96, School Science & Mathematics, 01-01-1996, pp 10.)

 

Myth 1: Hypotheses Become Theories Which Become Laws

 

 

This myth deals with the general belief that with increased evidence there is a developmental sequence through which scientific ideas pass on their way to final acceptance. Many believe that scientific ideas pass through the hypothesis and theory stages and finally mature as laws. A former U.S. president showed his misunderstanding of science by saying that he was not troubled by the idea of evolution because it was “just a theory.” The president’s misstatement is the essence of this myth; that an idea is not worthy of consideration until “lawness” has been bestowed upon it.

 

 

Myth 2: A Hypothesis is an Educated Guess

 

The term hypothesis has at least three definitions, and for that reason, should be abandoned, or at least used with caution. For instance, when Newton said that he framed no hypothesis as to the cause of gravity he was saying that he had no speculation about an explanation of why the law of gravity operates as it does. In this case, Newton used the term hypothesis to represent an immature theory.

 

Myth 3: A General and Universal Scientific Method Exists

 

 

…The steps listed for the scientific method vary from text to text but usually include, a) define the problem, b) gather background information, c) form a hypothesis, d) make observations, e) test the hypothesis, and f) draw conclusions. Some texts conclude their list of the steps of the scientific method by listing communication of results as the final ingredient.

 

One of the reasons for the widespread belief in a general scientific method may be the way in which results are presented for publication in research journals. The standardized style makes it appear that scientists follow a standard research plan. Medawar (1990) reacted to the common style exhibited by research papers by calling the scientific paper a fraud since the final journal report rarely outlines the actual way in which the problem was investigated.

 

Myth 4: Evidence Accumulated Carefully Will Result in Sure Knowledge

 

Scientists formulate laws and theories that are supposed to hold true in all places and for all time but the problem of induction makes such a guarantee impossible

 

The nature of induction itself is another interesting aspect associated with this myth. If we set aside the problem of induction momentarily, there is still the issue of how scientists make the final leap from the mass of evidence to the conclusion. In an idealized view of induction, the accumulated evidence will simply result in the production of a new law or theory in a procedural or mechanical fashion. In reality, there is no such method. The issue is far more complex — and interesting –than that. The final creative leap from evidence to scientific knowledge is the focus of another myth of science.

 

 

Myth 5: Science and its Methods Provide Absolute Proof

 

The problem of induction argues against proof in science, but there is another element of this myth worth exploring. In actuality, the only truly conclusive knowledge produced by science results when a notion is falsified. What this means is that no matter what scientific idea is considered, once evidence begins to accumulate, at least we know that the notion is untrue…whether scientists routinely try to falsify their notions and how much contrary evidence it takes for a scientist’s mind to change are issues worth exploring.

 

Myth 6: Science Is Procedural More Than Creative

 

Induction makes use of individual facts that are collected, analyzed and examined. Some observers may perceive a pattern in these data and propose a law in response, but there is no logical or procedural method by which the pattern is suggested. With a theory, the issue is much the same. Only the creativity of the individual scientist permits the discovery of laws and the invention of theories. If there truly was a single scientific method, two individuals with the same expertise could review the same facts and reach identical conclusions. There is no guarantee of this because the range and nature of creativity is a personal attribute.

 

Myth 7: Science and its Methods Can Answer All Questions

 

Philosophers of science have found it useful to refer to the work of Karl Popper (1968) and his principle of falsifiability to provide an operational definition of science. Popper believed that only those ideas that are potentially falsifiable are scientific ideas.

 

Science simply cannot address moral, ethical, aesthetic, social and metaphysical questions.

 

 

Myth 8. Scientists are Particularly Objective

 

 

contributions from both the philosophy of science and psychology reveal that there are at least three major reasons that make complete objectivity impossible.

 

Many philosophers of science support Popper’s (1963) view that science can advance only through a string of what he called conjectures and refutations. In other words, scientists should propose laws and theories as conjectures and then actively work to disprove or refute those ideas…. From a philosophical perspective the idea is sound, but there are no indications that scientists actively practice programs to search for disconfirming evidence.

 

Another aspect of the inability of scientists to be objective is found in theory-laden observation, a psychological notion (Hodson, 1986). Scientists, like all observers, hold a myriad of preconceptions and biases about the way the world operates. These notions, held in the subconscious, affect everyone’s ability to make observations. It is impossible to collect and interpret facts without any bias…. Certain facts either were not seen at all or were deemed unimportant based on the scientists’s prior knowledge. In earlier discussions of induction, we postulated that two individuals reviewing the same data would not be expected to reach the same conclusions. Not only does individual creativity play a role, but the issue of personal theory-laden observation further complicates the situation.

 

 

…scientists work within a research tradition called a paradigm. This research tradition, shared by those working in a given discipline, provides clues to the questions worth investigating, dictates what evidence is admissible and prescribes the tests and techniques that are reasonable. Although the paradigm provides direction to the research it may also stifle or limit investigation. Anything that confines the research endeavor necessarily limits objectivity. While there is no conscious desire on the part of scientists to limit discussion, it is likely that some new ideas in science are rejected because of the paradigm issue. When research reports are submitted for publication they are reviewed by other members of the discipline. Ideas from outside the paradigm are liable to be eliminated from consideration as crackpot or poor science and thus do not appear in print.

 

 

Myth 9. Experiments are the Principle Route to Scientific Knowledge

 

 

…True experiments involve carefully orchestrated procedures along with control and test groups usually with the goal of establishing a cause and effect relationship. Of course, true experimentation is a useful tool in science, but is not the sole route to knowledge.

 

… Scientific knowledge is gained in a variety of ways including observation, analysis, speculation, library investigation and experimentation.

 

 

Myth 10.  All Work in Science is Reviewed to Keep the Process Honest.

 

… professional scientists are also constantly reviewing each other’s experiments to check up on each other. Unfortunately, while such a check and balance system would be useful, the number of findings from one scientist checked by others is vanishingly small In reality, most scientists are simply too busy and research funds too limited for this type of review.

 

The result of the lack of oversight has recently put science itself under suspicion. With the pressures of academic tenure, personal competition and funding, it is not surprising that instances of outright scientific fraud do occur. However, even without fraud, the enormous amount of original scientific research published, and the pressure to produce new information rather than reproduce others’ work dramatically increases the chance that errors will go unnoticed.

 

 

 

What is Junk Science? Junk science is defined by Wikipedia as:

 

Junk science is a term used in U.S. political and legal disputes that brands an advocate’s claims about scientific data, research, analyses as spurious. The term conveys a pejorative connotation that the advocate is driven by political, ideological, financial, or other unscientific motives.

The term was first used in relation to expert testimony in civil litigation. More recently, it has been used to criticize research on the harmful environmental or public health effects of corporate activities, and occasionally in response to such criticism. “Junk science” is often counterposed to “sound science“, a term used to describe studies that favor the accuser’s point of view. It is the role of political interests which distinguishes debate over junk science from discussions of pseudoscience and controversial science.

 

So basically, junk science is scientific data and analysis that is ‘faulty’ and used to advance hidden agendas. Who then uses Junk Science?

 

 

1. The media for attention-getting headlines, and/or used for social or political agendas.

 

2. Social Activists to achieve social or political gain/change or to change beliefs.

 

3. Injury lawyers to award compensation and win large verdicts.

 

4. Government regulators as a way to increase budgets or expand their authority.

 

5. Individual Scientists to achieve fortune, fame, and can be used by the government for   their purposes.

 

6.  Businesses to make negative claims against their competitors.

 

7.  Politicians to gain favor with activist groups.

 

 

Junk Science, or otherwise known as pseudoscience, has no single ‘test’ that distinguishes it between science and junk science. There are differences that can become apparent and these differences are consistent. For instance:

 

1.  The primary goal of science is to achieve a more complete and more unified understanding of the physical world.

 

Pseudosciences are more likely to be driven by ideological, cultural, or commercial goals.

 

 

2.  Most scientific fields are the subjects of intense research which result in the continual expansion of knowledge in the discipline.

 

Pseudosciences -The field has evolved very little since it was first established. The small amount of research and experimentation that is carried out is generally done more to justify the belief than to extend it.

 

 

3.  Science-Workers in the field commonly seek out counterexamples or findings that appear to be inconsistent with accepted theories.

 

In the pseudosciences, a challenge to accepted dogma is often considered a hostile act if not heresy, and leads to bitter disputes or even schisms.

 

 

4.  Observations or data that are not consistent with current scientific understanding, once shown to be credible, generate intense interest among scientists and stimulate additional studies.

 

Pseudosciences – Observations or data that are not consistent with established beliefs tend to be ignored or actively suppressed.

 

5.  Science is a process in which each principle must be tested in the crucible of experience and remains subject to being questioned or rejected at any time.

 

Pseudosciences – The major tenets and principles of the field are often not falsifiable, and are unlikely ever to be altered or shown to be wrong.

 

6.  Scientific ideas and concepts must stand or fall on their own merits, based on existing knowledge and on evidence.

 

Pseudoscientific concepts tend to be shaped by individual egos and personalities, almost always by individuals who are not in contact with mainstream science. They often invoke authority (a famous name, for example) for support.

 

 

7.  Scientific explanations must be stated in clear, unambiguous terms.

 

Pseudoscientific explanations tend to be vague and ambiguous, often invoking scientific terms in dubious contexts.

 

 

 

How is Junk Science used in public relations? Most often it is in the disguise of public ‘health’ or ‘environment protection’. They will seek to prove conclusions are true for an economic profit. It is often done by attaching famous ‘scientists’ names. Only when it becomes too obvious to hide the truth, will a quiet phase out take place. Anyone who speaks out against the agenda, that is bought and paid for, will be debunked and labeled ‘junk science’, even if it is true. What is often deemed ‘junk science’, by those in a higher standing in the scientific community, defends something that threatens the health agenda or the environment for the good of all.

 

..to be continued