Supreme Court of the United States

23 Seniors Have Died So Far This Year After Receiving Flu Shots.

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Package insert for Fluzone flu vaccine marketed to seniors reveals 23 seniors died during drug trial

The annual marketing campaign pushing people to receive flu vaccinations is in full force. CVS Pharmacies is offering a 20% off shopping pass if you purchase a flu vaccine.

As you can see in the screen shot below, taken from the CVS website, senior citizens over the age of 65 are being targeted to get the “high-dose” flu vaccine.

The FAQ at the CVS website defines the “high-dose” flu vaccine: “Containing four times the amount of antigen (the part of the vaccine that causes the body to produce antibody) in regular flu shots, high-dose flu shots, along with the additional antigen produced, are intended to create a stronger immune response.”

The name of this flu vaccine that is marketed for seniors is called “Fluzone.” You can find it being marketed to seniors at all the major pharmacies in the United States.

Package inserts for flu vaccines show a multitude of side effects, including death, and yet they are marketed the same as over-the-counter drugs with no prescription needed. Why?

Because in the United States vaccines enjoy complete immunity from lawsuits in the market place. If you are injured or die from a vaccine, you or your family cannot sue the manufacturer of the vaccine. This law enacted by Congress, was upheld by the U.S. Supreme Court in 2011.

Therefore, they are marketed with the same marketing techniques as any other high-profit product. With the baby boomer generation moving into their senior years, today’s seniors are seen as an especially lucrative market.

So financial incentives like discounts on other products, as CVS is doing, is quite common in order to boost vaccine sales.

Walgreens has a different program that especially boosts sales of vaccines:

While vaccine rates in the U.S. among children are close to 90%, rates in other parts of the world (where pharmaceutical companies do not have immunity from the law for adverse effects) are much lower. So, in partnership with Walgreens, a non-profit organization (Shot@Life) buys up the vaccines and sends them to these countries for free (who doesn’t want something for free, especially when you live in a poor country??)

This is a brilliant marketing plan for the pharmaceutical companies, as the U.S. government gives the organization buying the vaccines non-profit status, allowing them to receive tax deductible donations to pay for the vaccines. Walgreens is probably a contributor to the program as a tax write off.

With legal immunity to market dangerous products, don’t expect those doing the marketing and making the profits to warn you of the side effects. You need to find this information yourself, usually from the Internet.

For those pro-vaccine forces that warn people how dangerous it is to get information from the Internet, the information we are about to share is directly from the FDA website (at least at the time of this writing – they have been known to remove items from their website if it gets too much publicity and makes them look bad), and you can look it up yourself.

The high-dose Fluzone vaccine being marketed this flu season to seniors, which has four times the amount of antigens that the regular flu shot has, as well as the non-high dose version, had 23 seniors die during drug trials.

In the section documenting adverse effects, this is what is written:

Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event. No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during the period Day 29–180 post-vaccination: (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone 1 recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

This statement stating that 23 seniors died, which really should be headline news but is buried in a package insert on the FDA website, begs several questions:

1. By what basis can they conclude that “No deaths were considered to be caused by vaccination”??

2. If, as it is implied, these 23 deaths were all caused by pre-existing conditions, why were there no deaths in the first 28 days? Shouldn’t the deaths, if not attributable to the vaccine but pre-existing conditions, be equally spread out through all time periods?
3. How does the medical history for these 23 seniors compare to the medical history of those who did not die? Were there any significant differences? The range of symptoms given in the package insert can very well cover almost all seniors during the flu season.

Besides death, which is just one “serious adverse event,” there were 226 other “serious” adverse events, for a total of 249 serious adverse events, out of only 3,833 participants.

If this does not constitute a dangerous drug that should probably not even be on the market, then I don’t know what does. And yet, it is sold to unsuspecting seniors and others like candy at these drug stores.

One of these other adverse side effects (besides death) is Guillain-Barré syndrome, which has symptoms similar to polio. If you are brought into an emergency room with the paralyzing effects of Guillain-Barré syndrome (GBS), the first question the doctors will ask you is if you just received the flu shot. Read one story here of how one man went from being able to bench-press 275 pounds to struggling how to walk after receiving last year’s flu shot: Miami Man Contracts Guillain-Barré Syndrome, Nearly Dies After Getting Flu Shot.

The CDC would like you to believe that the risk of GBS from the flu shot is only one out of one million. But if that is the case, why is there a warning on package inserts of flu vaccines, and why is it the first question EMTs ask when dealing with GBS emergencies?

The package insert for Fluzone states: “If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.”

I wonder how many vaccine sales people at these pharmacies give “careful consideration” to this adverse side effect, or any others, before injecting you?

 

Source: undergroundhealth.com

      

Who Owns Human Genes?

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Angelina Jolie’s recent disclosure that she had undergone a prophylactic double mastectomy following a positive test for a BRCA1 mutation (which increases lifetime breast cancer risk by 60%-87%) prompted a national conversation about genetic testing and preventive surgery.1 Tests for BRCA1 and BRCA2 cost more than $3000, placing them beyond the reach of many women. The high cost is partly a consequence of intellectual property protection afforded to Myriad Genetics Inc, which sequenced the genes and developed the testing capability.

The Patent Act permits exclusive control for a limited time (currently 20 years) of any “process, machine, manufacture, or composition of matter.” Following a US Supreme Court ruling upholding the patentability of a microbe that dissolves oil,2 the US Patent and Trademark Office (USPTO) began routinely granting gene patents. On June 13, 2013, the US Supreme Court unanimously held that extracted and isolated DNA is a product of nature and not eligible for patent, but that complementary DNA (cDNA), which is synthetic DNA created in the laboratory, is patentable because it is not naturally occurring.3

The compromise ruling acknowledged difficult issues in a simmering controversy. Granting commercial rights over naturally occurring biological products seemed unethical because industry should not be able to control access to unaltered materials found in nature. However, failure to afford intellectual property protection could stifle innovation, robbing entrepreneurs of financial incentives for discovery. Myriad lost the exclusive right to isolate the BRCA1 and BRCA2 genes of individuals, but maintained the right to its unique method of synthetically creating BRCA cDNA to produce and market its tests.

SHAPING THE COURSE OF RESEARCH

The Court’s decision will influence the future of human genome research. The rapidly evolving capacity to sequence the genome will usher in an era of relatively inexpensive screening for multiple risks. Myriad plans to phase out BRCA gene tests by mid-2015, marketing instead a more comprehensive test panel for 25 genes. Competitor laboratories will also introduce panels, ultimately enabling detection of hundreds of genes.5

Research will be affected beyond human genetics; for example, researchers will likely challenge existing patents on bacterial genes. The Court’s decision may also affect intellectual property protection afforded to a wide variety of naturally occurring substances, such as innovations derived from microorganisms or plants.

Ideally, the law ought to facilitate science as well as make lifesaving technologies more affordable and accessible. The future should be filled with excitement as scientists and innovator companies expand the horizon of medical technologies to prevent, detect, and treat human diseases. Achieving this vision will require massive public investment, private innovation, and the useful application of new diagnostics and pharmaceuticals through the health care system.

REFERENCES

1

Jolie A. My medical choice. New York Times. May 14, 2013; A25.

2

Diamond v Chakrabarty, 447 US 303 (1980).

3

Association for Molecular Pathology v Myriad Genetics, 569 US ___ (2013).

4

Mayo Collaborative Services v Prometheus Laboratories, Inc, 132 S Ct 1289 (2012).

5

Pollack A. After DNA patent ruling, availability of genetic tests could broaden. New York Times. June 14, 2013; A16.

Source: JAMA

 

 

The FDA’s Graphic Tobacco Warnings and the First Amendment.

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In the past, constitutional principle gave the government broad authority to regulate tobacco or pharmaceutical advertising. The state’s power to safeguard the public health was strong, and companies’ freedom to plug their products was weak.

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But the Supreme Court has changed course. Whereas it once did not view “commercial” speech as the kind of speech the First Amendment protects, it now gives businesses nearly the same rights to market their goods as it does individuals to speak their minds. And as the Court has broadened corporate freedom to advertise, it has narrowed governmental power to preserve the public’s health. Whereas the Court once gave the government more leeway when invoking its interests in public health than when asserting other state interests, it now tends to hold health-related rules to the same constitutional standards as other types of rules.1

As a result, government today is much more susceptible to challenge when it tries to regulate the promotional activities of the tobacco or pharmaceutical industry. In 2011, the Supreme Court rejected Vermont’s effort to restrict the use of prescription data by drug companies’ sales representatives.2 And last year, the U.S. Court of Appeals for the D.C. Circuit vetoed the new graphic warnings for cigarette packages that had been issued by the Food and Drug Administration (FDA).3 The Supreme Court’s increasing sympathy for corporate speech and decreasing deference to public health authorities makes it more difficult for government to protect the public’s health. The fate of the graphic cigarette warnings is illustrative.

Congress authorized the graphic warnings when it passed the Family Smoking Prevention and Tobacco Control Act in 2009. The Act requires the use of nine new textual warnings for cigarette packages and directs the Department of Health and Human Services to select color graphics to accompany the warnings. The images have to depict the “negative health consequences” of smoking, with text and graphic taking up the top halves of each pack’s front and back panels.

In June 2011, the FDA unveiled the nine images, including some that were quite explicit. One image showed a man smoking through a tracheostomy (see image). Another showed the corpse of a man with staples in his chest on an autopsy table. Several tobacco companies promptly sued, alleging that the graphic-warning requirements violated their First Amendment rights. The companies prevailed in both the district court and the D.C. Circuit.

In one sense, the result was not surprising, given the Supreme Court’s increased sympathy toward corporations and their First Amendment rights. Regulations of commercial speech often succumb to judicial scrutiny.

However, there was good reason to think that the D.C. Circuit would uphold the graphic warnings. Even as the Supreme Court has narrowed the power of government to regulate corporate speech, it has preserved an important authority to regulate. The graphic warnings seemed to fall within that authority.

The preserved authority reflects the distinction the Supreme Court makes between the regulation of corporate speech that informs and the regulation of corporate speech that misinforms. On the one hand, the Court usually objects when the government tries to block truthful speech by businesses. In the prescription-data case, the Vermont law would have restricted the free flow of information about physicians’ prescribing practices. On the other hand, the Court typically approves when the government tries to prevent false or deceptive speech by businesses. For example, the government may forbid companies from saying things that are not true. It also may require companies to make disclosures that will allow consumers to make informed choices and not be misled by advertising hype. Common disclosure requirements include the corporate prospectus for stock offerings, the total interest payments for a home mortgage, nutritional information for foods, and the textual warnings for cigarettes.

The graphic cigarette warnings appeared to serve purposes similar to those of other required disclosures. The warnings would promote understanding of the risks of smoking and prevent people from being misled by cigarette marketing.

Indeed, the U.S. Court of Appeals for the Sixth Circuit had upheld Congress’s authority to mandate graphic warnings.4 As that court observed, people often do not read textual warnings on cigarette packages. And even when read, the warnings may not be effective in informing consumers about the risks to their health. Adding color images can ensure that textual warnings are noticed, read, and understood. Sometimes a picture really is worth a thousand words.

Even though the Supreme Court let the Sixth Circuit’s decision stand, its effect is limited. The Sixth Circuit considered only whether Congress may require some graphic warnings. The D.C. Circuit considered the constitutionality of the FDA’s actual warnings.

In rejecting the warnings by a two-to-one vote, the D.C. Circuit identified two problems. First, the majority did not think the images were needed to prevent cigarette companies from misleading consumers. Other statutory provisions already prohibited many kinds of deceptive labeling or advertising. The court was not willing to defer to the FDA’s judgment that the new images were necessary. Second, the warnings were not designed simply to ensure that consumers fully understand the risks to their health from cigarettes. Instead, wrote the majority, the warnings would primarily serve to convey the government’s antismoking message. Indeed, each of the new images would include the phone number for the National Cancer Institute‘s tobacco cessation hotline, 1-800-QUIT-NOW. Whereas government may use its own resources to publicize its perspectives, it generally may not force individuals or corporations to spend their dollars to disseminate its viewpoint.

Rather than seek Supreme Court review of the D.C. Circuit’s decision, the FDA opted to return to the drawing board and develop new graphic warnings. In the meantime, we are left with some important questions.

First, when do graphic warnings cross the line between trying to inform and trying to persuade? Does it depend on how “shocking” or how prominent they are? Two of the three D.C. Circuit judges thought that the images were designed to evoke an emotional response rather than to convey factual information. The dissenting judge cited the FDA’s point that warnings more effectively communicate information when they elicit a strong emotional reaction. In addition, the images would provide information about risk when viewed in conjunction with their accompanying text. For example, the image of the man smoking through a tracheostomy accompanied the warning “Cigarettes are addictive” and would have illustrated the tenacity of nicotine addiction. In the dissenter’s view, the images would have been acceptable without the cessation hotline number.

Second, must the warnings correct misleading impressions from the company’s cigarette packaging or current advertisements, or may they also correct misimpressions from past promotional materials?

Third, if courts will not defer to the judgment of public health authorities about the need for disclosure mandates, what kind of empirical evidence must the FDA present in order to justify the use of graphic warnings?

Whatever the answers to these questions, companies today are better able to promote their products, and government is less able to promote health than was the case in the past. Ironically, early protection of commercial speech rested in large part on the need to serve consumers’ welfare. In 1976, for example, the Supreme Court struck down a Virginia law that prevented pharmacists from advertising their prices for prescription drugs.5 The law especially hurt persons of limited means, who were not able to shop around and therefore might not be able to afford their medicines. Today, by contrast, courts are using the First Amendment to the detriment of consumers’ welfare, by invalidating laws that would protect the public health.

 

REFERENCES

  1. 1

Orentlicher D. The commercial speech doctrine in health regulation: the clash between the public interest in a robust First Amendment and the public interest in effective protection from harm. Am J Law Med 2011;37:299-314
Web of Science | Medline

  1. 2

Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011).

  1. 3

R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012).

  1. 4

Disc. Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012).

  1. 5

Virginia State Bd. of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976)

Source: NEJM