Mike Adams, the Health Ranger See article keywords and concepts |
Vioxx whistleblower Dr. graham says the FDA not only doesn't protect consumer interests, but cannot
During Grassley's November hearing, Dr. David graham, senior drug safety researcher at the FDA, (and Vioxx whistleblower) testified before the Committee that the FDA was "incapable of protecting America from unsafe drugs or from another Vioxx." In an interview with Manette Loudon, lead investigator for Dr. Gary Null, Dr. graham said that since his testimony before the Committee, "...very little has changed on the surface [of the FDA] and substantively nothing has changed. |
J. Douglas Bremner See book keywords and concepts |
It was only the tip of the iceberg. graham identified five widely prescribed drugs still on the market that are particularly dangerous, including Accutane, Bextra, Crestor, Me-ridia, and Serevent. (In 2005 Bextra was taken off the market.)
While it's true that many drugs help people live longer and better lives, myriad others may be harmful in ways you're unaware of. Dr. Graham's testimony provided the public a fleeting glimpse of the knowledge that is normally hidden from view or frustratingly difficult for the average person to access. |
Craig Pepin-Donat See book keywords and concepts |
On November 18, 2004, graham testified before the Senate Finance Committee regarding the Vioxx recall issue and the FDA approval process. I have read almost every media publication on the Vioxx issue, but not until I read his complete testimony did I realize the extent to which there is a major problem with the drug approval process within the FDA. By testifying, graham placed himself at risk of being ostracized by the FDA community. He ignored that risk and instead had the courage to come forward in the public interest to try to effect positive change in the drug approval process. |
| Estimates that Vioxx caused at least 28,000 cases of heart attack or sudden cardiac death are "extremely conservative," according to graham, who blamed flaws within the agency for the 'Vioxx catastrophe."10 More to the point, he claimed to have studies showing deaths related to Vioxx in excess of one hundred forty thousand people. Both of the studies were subsequently published in the September 12, 2006, online edition of the Journal of the American Medical Association."
Graham's credentials are impeccable. |
| Graham posted details about the magnitude of the mistake on the agency
Web site. "From 1999 to 2003, there were an estimated 92,791,000 prescriptions for Rofecoxib (Vioxx), of which 17.6 percent were high-dose." In the same year, Vioxx sales reached $2.5 billion. Estimates that Vioxx caused at least 28,000 cases of heart attack or sudden cardiac death are "extremely conservative," according to graham, who blamed flaws within the agency for the 'Vioxx catastrophe."10 More to the point, he claimed to have studies showing deaths related to Vioxx in excess of one hundred forty thousand people. |
Erich Grotewold See book keywords and concepts |
An update on recent developments, J Mass Spectrom 37: 241-253. graham, T. L., 1991a, A rapid, high-resolution high performance liquid chromatography profiling procedure for plant and microbial aromatic secondary metabolites, Plant Physiol 95: 584-593. graham, T. L., 1991b, Flavonoid and isoflavonoid distribution in developing soybean seedlings tissues and in seed and root exudates, Plant Physiol 95: 594-603. Gu, L., and Gu, W. |
Joerg Gruenwald, Ph.D. See book keywords and concepts |
Graham B, In: graham HN: Tea: The Plant and Its Manufacture, Chemistry, and Consumption of the Beverage. In: The Methylxanthine Beverages and Foods: Chemistry, Consumption, and Heath Effects, Alan R. Liss, New York, S.29-74. 1984.
Haslam E, Natural polyphenols (vegetable tannins) as drugs: possible modes of action. In: JNP 59(2):205-215. 1996.
Imai K, Nakachi K, Cross sectional study of effects of drinking green tea on cardiovascular and liver disease. In: Brit Med J 310:693-696. 1995. |
Mike Adams, the Health Ranger See article keywords and concepts |
David graham, a drug safety officer with the FDA's Office of Surveillance and Epidemiology, estimates that Avandia has caused as many as 205,000 heart attacks and strokes, some of them fatal, between 1999 and 2006. Graham's analysis indicates that since Avandia was approved, some 80,000 patients have died from the drug's side effects. For every month that Avandia is sold, he said, 1,600 to 2,200 patients will suffer more of these events. |
Lester A. Mitscher and Victoria Toews See book keywords and concepts |
Harold graham remarked that the "scavenging effects of green tea extracts and green tea polyphenol fractions are superior to those of ascorbic acid (vitamin C) and tocopherol (vitamin E) with respect to some active oxygen radicals but are less pronounced with hydroxyl free radicals."12 In other words, Dr. graham had found that green tea, under some circumstances, was a more powerful antioxidant than vitamin C and vitamin E, although there are other situations where those two antioxidant vitamins are more effective than green tea. |
David W. Grotto, RD, LDN See book keywords and concepts |
Sandy Tomich—"Ma"
Giselle Ruecking—goddaughter extraordinaire
Treena and graham Kerr—authors; www.grahamkerr.com
Michael Sena and Kirsten Straughan RD, LD—authors, Lean Mom, Fit Family:
The 6-Week Plan for a Slimmer You and a Healthier Family (Rodale, 2005) A very special thank-you to my good friend J. Hugh McEvoy, CRC, CEC—aka
"Chef J," who graciously contributed 21 of the 101 delicious recipes; and to my wonderful wife, Sharon, who came up with a boatload of yummy dishes that kept our family well fed. |
| A cups graham cracker crumbs 2 tablespoons butter, melted 2 tablespoons honey for the filling:
12 ounces elderberries
'A cup honey
I teaspoon vanilla extract
'A cup water
1 tablespoon cornstarch
2 cups low-fat strawberry ice cream or frozen yogurt
2 cups low-fat vanilla ice cream or frozen yogurt directions (crust):
Place graham cracker crumbs, honey, and butter in a 9-inch pie plate. Mix and firmly press mixture to form pie crust. Place in freezer for thirty minutes. |
Thomson Healthcare, Inc. See book keywords and concepts |
Graham B, In: graham HN. Tea: The Plant and Its Manufacture, Chemistry, and Consumption of the Beverage. In: The Methylxanthine Beverages and Foods: Chemistry, Consumption, and Heath Effects, Alan R. Liss, New York, S.29-74. 1984.
Gupta S, Ahmad N, Nieminen AL et al. Growth inhibition, cell-cycle dysregulation, and induction of apoptosis by Green Tea constituent (-)- epigallocatechin-3-gallate in androgen-sensitive and androgen insensitive human prostate carcinoma cells. Toxicol Appl Pharmacol; 164(l):82-90. 2000.
Hakim IA, Harris RB & Weisgerber UM. |
Mark Schapiro See book keywords and concepts |
Among those are the center's former president, John graham, who was appointed head of the Office of Management and Budget. In that position, graham went on to accelerate many of the internal rule changes that Gray had advocated during his tenure in the White House under Bush Sr.
In 2002, Gray went after the other critical leg of environmental protection: the judiciary. He cofounded the Committee for Justice, which played a central role in supporting President Bush's judicial nominees, many of whom are drawn from the very industries overseen by the EPA. |
Sophie D. Coe and Michael D. Coe See book keywords and concepts |
A few decades ago the writers Evelyn Waugh and graham Greene could be seen looking out from its famous bow window. Among today's 1350 members are more than 30 earls, 11 marquesses, and a half dozen dukes.
But not all frequenters of 18th-century chocolate and coffeehouses were decision-makers or even gamblers, as Number 54 of The Spectator (1711) makes clear. In it, the editor claims to have received a communication from a correspondent at the University of Cambridge, identifying a "Sect of Philosophers" named Loumgers, who contrive to spend their days doing nothing. |
David W. Grotto, RD, LDN See book keywords and concepts |
Corn Chowder
Adapted from The Gathering Place by graham Kerr Servings: 6 • Prep and cooking time: 60 minutes
This recipe contains five powerhouse foods. |
Mike Adams, the Health Ranger See article keywords and concepts |
Dr. graham on the dangers of Ketek,” said Sen. Charles Grassley. “The F.D.A. has made it their business to discredit Dr. graham and others who aren’t willing to cater to the drug companies.”
Sen. Grassley is a frequent observer and critic of FDA activity, and has worked on legislation to reform the agency.
How long will FDA fraud be allowed to continue? |
| The drug, Dr. graham explains, is at least as toxic to the liver as three other drugs that have been pulled by the FDA. Furthermore, the FDA's original approval of the drug was based on a safety study that FDA officials knew was fraudulent.
The FDA's approval of Ketek, Dr. graham wrote in a June 16 email, was a mistake. “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin [Ketek] is concerned,” he wrote. |
Peter Rost See book keywords and concepts |
Senate at the end of 2004 about how the FDA treated Merck with kid gloves and was reluctant to remove Vioxx from the market. graham told the committee he was intimidated by FDA officials after a study he conducted showed Vioxx increased the risk of heart attack. Twenty-two members of Congress signed a letter to acting FDA commissioner Lester Crawford. The letter said the members wanted "to express our strong dismay at recent reports about efforts taken by some at FDA to discredit and smear Dr. graham. |
Mike Adams See book keywords and concepts |
David graham, a senior drug safety researcher. Dr. Graham's review of Rezulin turned up even more frightening conclusions about the drug:
Patients incurred 1,200 times higher risk of liver failure from taking Rezulin.
One out of every 1,800 patients taking Rezulin could be expected to suffer liver failure (a number far greater than the one-in-100,000 risk claimed by Warner-Lambert).
The antibiotic Ketek has been shown to damage the liver and sometimes cause death after a few doses...yet it is still prescribed today, to children. |
Mike Adams, the Health Ranger See article keywords and concepts |
In his interview with Loudon, Dr. graham put it nicely: "As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of the industry. It views industry as its client, and the client is someone whose interest you represent."
The Government Accountability Office has said the FDA must change to protect the public. Sen. Grassley and the Senate Committee on Finance came to the same conclusion. |
| Grassley's GAO investigation results were announced in April 2006. Dr. Graham's interview with Loudon was published in August 2005. The troubles with Vioxx began in September 2004. The FDA says it has actions planned to fix its critical drug safety failures, but given the amount of time passed since its shortcomings were first noticed nearly three years ago, shouldn't it have remedied some of its more crucial faults already? Perhaps, even in light of all the recent criticisms raining down on it, the FDA will simply issue another press release to Sen. |
| Gary Null, Dr. graham said that since his testimony before the Committee, "...very little has changed on the surface [of the FDA] and substantively nothing has changed. The structural problems that exist within the FDA, where the people who approve the drugs are also the ones who oversee the post-marketing regulation of the drug, remain unchanged. The people who approve a drug when they see that there is a safety problem with it are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur. |
Jeffrey M. Smith See book keywords and concepts |
The soy used in the study was also largely GM. John graham, spokesman for the York laboratory, said, "We believe this raises serious new questions about the safety of GM foods."93
GM soy has unique allergic response
Remarkably, no follow-up tests to the UK allergy study were conducted at the time to see if individuals reacted differently to GM and non-GM soybeans. A study published six years later, however, verified that the immune system of some individuals does react differently to the two soy types. |
Mark Schapiro See book keywords and concepts |
The scholarly journal Asia Policy published a paper coauthored by Chaoyi Zhao, a research fellow at the China National Institute of Standardization, a division within China's government standard-setting apparatus, and John M. graham, a Next Generation Fellow at the National Bureau of Asian Research, a U.S. think tank affiliated with Tsinghua University. The two men wrote of the largely unrecognized competitive power that lies behind the setting of standards —whether they be standards governing technology, safety, and financial management, or those governing environmental protection. |
Greg Critser See book keywords and concepts |
About half a million patients a year were going on Arava by 2003.
But graham was not allowed personally to present his findings to the FDA safety committee on Arava. Instead, his memo was provided with cover letters by the head of the original review committee that approved the drug. Those letters vigorously spun Graham's warning and downplayed its recommendation. "We could not understand why David was not allowed to present," says Public Citizen's Larry Sasich. |
Mark Schapiro See book keywords and concepts |
In that position, graham went on to accelerate many of the internal rule changes that Gray had advocated during his tenure in the White House under Bush Sr.
In 2002, Gray went after the other critical leg of environmental protection: the judiciary. He cofounded the Committee for Justice, which played a central role in supporting President Bush's judicial nominees, many of whom are drawn from the very industries overseen by the EPA. |
Greg Critser See book keywords and concepts |
Those letters vigorously spun Graham's warning and downplayed its recommendation. "We could not understand why David was not allowed to present," says Public Citizen's Larry Sasich. The committee's "data was straight out of the drug maker's database, which represented people who were being carefully watched and tended to. David's was a view of the real-world harm of the drug, where people are not so carefully tended and treated." Arava was kept on the market, and remains there to this day.
Graham holds a pointed interpretation of the experience. |
Charles Barber See book keywords and concepts |
Lawrence, Ernest Hemingway, graham Greene, Jack Kerouac, Bob Dylan.
Reentry by travel (sexual): Taking on a succession of lovers. Examples: D. H. Lawrence, Henry Miller, Anais Nin, Robert Mapplethorpe, Madonna.
Reentry by return: Returning to the place one left, as a way of controlling and understanding one's origin and one's life. Examples: None. Percy says, "You can't go home again."
Reentry by disguise: The aping of people who have successfully reentered the world. In other words, trying to be healthy-minded when you're not. |
Michael Friedman, ND See book keywords and concepts |
With lower doses, a smaller proportion become psychotic. graham,34-61 and graham, Tiffany, Bell, and Gutknecht35 are convinced a proportion of catecholamines were oxidized to quinines to amino-chromes to neuromelanin. This is so slow that little is found in brain until age 6. 6 hydroxy dopamine is toxic because it is converted to trihydroxyphenylala-nine (TOPA), which is converted to aminochrome. Thus, while it benefits the patient by moderating the symptoms, it accelerates the destruction of dopamine receptors. |