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FDA compromised by Drug Industry Timely Insights on Laws, Issues and New Developements

FDA LogoYou might consider the drugs you take safe if they’ve been approved by the FDA; but recent history should give you pause. The FDA has approved more than a dozen drugs in recent years which have later been recalled for safety problems: Vioxx, Bextra, Baycol, Darvon and Propulsid are just a few of the many. Several other dangerous drugs remain on the market despite being the subject of ongoing lawsuits filed by people who allege injury by those drugs. This list includes Zofran, Xarelto, Invokana, Lipitor, Paxil, Prosac, Zoloft, Topamax, , Potiga and many others.

FDA approves Dangerous Drug

Martha Rosenberg points out that the FDA has failed over the years in its stated mission to insure the safety of our food and drugs. Now, writes Ms. Rosenberg, the FDA has approved a drug so irritating to the esophagus that it can put you in the ER, and it has approved drugs like the bisphosphonate bone drugs or others that suppress the entire human immune system and invite cancers.

FDA compromised by Drug Industry

Over the last decade or so the FDA began serving Wall Street instead of the people. How else can one explain, asks Ms. Rosenberg, how the agency announced plans to tighten restrictions on hydrocodone combination products like Vicodin on the same day that it approved the drug Zohydro, which has 5-10 times the abuse potential of OxyContin?

‘First do no Harm’ to ‘First make a Profit’

The drug Onbrez is emblematic of the FDA’s shifted priorities. The agency’s own warnings state that long acting beta agonists (LABAs) for asthma “increase the risk of asthma-related death,” and “increase the risk of asthma-related hospitalization in pediatric and adolescent patients. ” Nevertheless, the FDA approved Onbrez, a new LABA containing drug.

While Onbrez was approved for chronic obstructive pulmonary disease or COPD, watchdog group Public Citizen warned that it “will certainly be used off-label in asthmatics, who would be placed at increased risk of serious adverse events, including death.”

FDA ignores Advisory Committees

The FDA in the past would routinely accept the recommendations of its own advisory committees. Why else would it bother to form advisory committees? But to add insult to idiocy with your tax dollars, in Nov. 2015 the FDA overrode a rejection conclusion from its own advisory committee for another respiratory drug, mepolizumab (Nucala). This drug is for asthma patients age 12 and above with a history of severe exacerbations from conventional maintenance therapy. The FDA ignored its own committee despite its contention that the drug had inadequate safety evidence for this age group.

Asthma Drugs Dubious

Nucala – like Humira, Remicide and Xolair – is an injected humanized monoclonal antibody biologic.” Big Pharma likes it because it generates thousands of dollars per patient each year. This dubious drug is also less threatened by generics than pills. The problem is that safety questions obtain with this drug class, known as ‘MoAbs.’  In only a year and a half, Xolair has been linked to a higher risk of heart attack, mini-stroke, chest pain, blood clots in the lungs and veins, as well as 77 life-threatening reactions.

Asthma Drug Deaths, Cancer

FDA announced in 2008 that 45 people died from fungal diseases while taking Humira, Enbrel, Remicade, Cimzia. The agency investigated 30 reports of childhood cancer, as well as links to lymphoma, leukemia, melanoma in Humira-using children.

Popular LABA drugs make Big Pharma millions but they are hardly safe. A giant trial of one, salmeterol, was halted after it resulted in 16 deaths, 44 intubations and 369 hospitalizations.

LABAs make Big Pharma so much money it’s hard for the industry to see the dangers for users. Symbicort, Dulera, Foradil, Advair Diskus, Serevent Diskus and the newer drug Onbrez do not replace long-term asthma control medication or “rescue” meds but are added as a third drug. The only “ value added” (as the markers say) in that scenario may be the bottom line for Big Pharma.

The FDA’s Dr. David Graham – among the first to discover the lethal problems with Vioxx – questions whether the new asthma drugs are even effective. At FDA hearings, Dr. Graham questioned whether LABAs had any benefit at all, and “seemed to be small compared to placebo.” He rejected the drug industry theory that a decline in U.S. asthma deaths over the last decade is due to the use of LABAs.

FDA Conflicts of Interest

Obama has nominated  for new FDA Commissioner, one Robert M. Califf, a longtime drug industry insider from the drug industry-supported Duke University. A disclosure statement on Duke Clinical Research Institute’s web site lists 25 drug companies that fund Califf. To help repay his paymasters, Califf defended the $5 arthritis/aspirin-like drug Vioxx, which was linked to 50,000 heart attacks. He also went to bat for the blood thinner Xarelto, which has been linked with more than 3,300 reports of uncontrolled bleeding and 379 deaths. Duke receives more than 60 percent of its funding from Big Pharma.

Martha Rosenberg noted that Califf admitted on NPR right in front of God and everybody:  “Many of us consult with the pharmaceutical industry.”

Protect Yourself

Since it is clear the FDA is dangerously linked with industry, you might want to protect yourself and your children and do your own research into the latest drug your doctor recommends. See also: Dollars for Docs.


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by Matthews & Associates

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