how the fda is recklessly abandoning drug safety

8/13/12 08:32 How the FDA is Recklessly Abandoning Drug Safety

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Shocking Story Reveals Howthe FDA Is RecklesslyAbandoning Drug Safety

By Dr. Mercola

In the wake of shocking reports onhow the FDA, terrified of being outedfor its questionable practices, spiedon its own employees in the hopes ofrooting them out before they couldbecome whistleblowers, a new storyhas emerged on how deep the deceitgoes. From marginalizing safety re-ports to not reading them at all!andthen going ahead and approving the



drugs in question!the FDA oncemore stands accused of being littlemore than a rubber-stamping agencyfor Big Pharma.

Explosive revelations of an intensivespy operation by the FDA on its ownscientists emerged last month. Usingsophisticated spy software, theagency tracked and logged everymove made by the targeted individu-als. The program even interceptedpersonal emails and copied docu-ments on their personal thumb dri-ves.

The targeted scientists had expressed

http://articles.mercola.com/sites/articles/archive/2012/07/18/mammography-rates-decline.aspx



concern over the agency’s approval ofdangerous medical imaging devicesfor mammograms and colonoscopies,which they believe expose patients todangerous levels of radiation. Now,another whistleblower has steppedforward, and what he has to sayabout the agency’s drug safety re-views is shocking even to the jaded...

Former FDA Reviewer Speaks OutAbout Systemic Suppression ofSafety

Ronald Kavanagh was a drug review-er for the FDA in the Center for Drug



Evaluation and Research from 1998 to2008. In a recent interview he revealshow the FDA bypassed or ignoredsafety issues on major drugs ap-proved during his employment. In aninterview for the online news maga-zine Truth-Out he tells Martha Rosen-berg:

“In the Center for Drugs [Centerfor Drug Evaluation and Researchor CDER], as in the Center for De-vices, the honest employee fears thedishonest employee.

There is also irrefutable evidencethat managers at CDER have placed



the nation at risk by corrupting theevaluation of drugs and by interfer-ing with our ability to ensure thesafety and efficacy of drugs. While Iwas at FDA, drug reviewers wereclearly told not to question drugcompanies and that our job was toapprove drugs. We were prevented,except in rare instances, from pre-senting findings at advisory com-mittees.

In 2007, formal policies were insti-tuted so that speaking in any waythat could reflect poorly on theagency could result in termination.If we asked questions that could de-



lay or prevent a drug's approval -which of course was our job as drugreviewers - management would rep-rimand us, reassign us, hold secretmeetings about us, and worse. Ob-viously in such an environment,people will self-censor.”

According to Kavanagh, peoplewould be shocked if they knew justhow malleable safety data is. As ex-amples, he points out that humanstudies are typically too short andcontain too few subjects to get a clearpicture of potential risks. In such ascenario, even a single case of a seri-ous adverse event must be taken very



seriously, and data from other longerterm safety studies also need to becarefully analyzed. Kavanagh claimshe has seen drug reviews where themedical safety reviewer completelyfailed to make such evaluations priorto the drug’s approval.

FDA Actively Thwarts Serious Safe-ty Investigations

There’s no telling how many ineffec-tive and/or dangerous drugs andmedical devices have been approvedand ushered into market throughsheer intimidation and bullying, ei-ther by pharmaceutical companies or



FDA management. Perhaps evenmore shocking are the revelationsthat some of the internal rules andregulations of the FDA are clearly de-signed to thwart serious safety re-views from the get-go.

According to Kavanagh:

“[H]uman clinical pharmacologytrials are typically done in Europe,yet clinical pharmacology reviewersat FDA have been barred from ana-lyzing this information prior tostudies being conducted in the US.Without being able to do this, we areunable to detect evidence of risks



early and cannot provide guidancethat would help with the develop-ment of the drug in terms not onlyof safety and proving efficacy, butalso with the efficiency and cost ef-fectiveness of the drug's develop-ment.”

Another loophole that can put yourhealth in serious jeopardy is that drugcompanies are not required to includeadverse events on the drug’s label ifthe adverse reaction is:

Below a certain percentage, and/orBelow double the rate of the ad-verse event found in a placebo




“By this rule, certain serious andpotentially lethal adverse eventsthat eventually resulted in a drugbeing withdrawn from the marketwould not have had any mention ofthe adverse events made in the label-ing at all.”

Kavanagh also claims to have discov-ered another common loophole usedby pharmaceutical companies to cir-cumvent safety issues. They’d simplysubmit bits and pieces of data to dif-ferent places, effectively preventingthe reviewer to pull it all together.



Then, because the safety issues falselyappeared to be negligible, it would bedecided that no further evaluationwould be necessary...

“On one occasion, the companyeven told me they were going to callupper management to get a clear re-quirement for approval that they didnot want to fulfill eliminated, whichI then saw happen. On another oc-casion a company clearly stated in ameeting that they had "paid for anapproval,” Kavanagh says.

“Sometimes we were literally in-structed to only read a 100-150 page



summary and to accept drug compa-ny claims without examining theactual data, which on multiple occa-sions I found directly contradictedthe summary document. Othertimes I was ordered not to reviewcertain sections of the submission,but invariably that's where the safe-ty issues would be. This could onlyoccur if FDA management was toldabout issues in the submission be-fore it had even been reviewed.

In addition, management wouldoverload us with huge amounts ofmaterial that could not possibly beread by a given deadline and would



withhold assistance. When you areable to dig in, if you found issuesthat would make you turn down adrug, you could be pressured to re-verse your decision or the reviewwould then be handed off to someonewho would simply copy and pastewhatever claims the company madein the summary document.”

Examples of Dangerous Drug Ap-provals

In his interview, Kavanagh discussessome of the dangerous drugs thatwere approved in the face of un-equivocal safety concerns. One is the



nerve gas drug pyridostigmine—aprophylactic drug against the nerveagent Soman. The drug was ap-proved under the "Animal Rule,"which allows drugs to be approvedbased on animal data alone. Therewere multiple problems with this ap-proval. First, the animal studies didnot reflect how the drug would beused in humans. Second, the drug ac-tually increases lethality if nerveagents other than Soman are used.


“This information was not secret -both FDA and DoD public docu-



ments acknowledge increased lethal-ity with other nerve agents such asSarin, and DoD and other govern-ment documents that are public alsodocument that Saddam Hussein wasnot using Soman and was insteadusing these other nerve agents ex-clusively.

Yet because I raised this as an objec-tion, I was immediately replaced asthe primary reviewer so that I couldnot document my concerns and sothat pyridostigmine could be ap-proved. It's since been proposed thatif we ever face the prospect of nerveagents in the future, that this ap-



proval will be used as a justificationto convince the President at thattime to waive informed consentwithout presenting a full picture.”

Pediatric drugs also end up posingunnecessary risks due to the FDA’sfailure to adequately review safetyrisks, and the many scientific loop-holes employed by pharmaceuticalcompanies. For example, the follow-ing flawed parameters are typicallyused in pediatric drug studies:

Dosages are based on approvedadult dosages, without regard formetabolic differences between a



developing child’s body and anadultExposure studies oftentimes useoverweight children, and includetoo few children to adequatelyevaluate risksNo allowances are made for race,age, puberty, or actual weight

Dangers to pregnant women andtheir developing fetuses are also fre-quently ignored. All in all, the FDAappears to be engaged in a systematichush-operation designed to give justabout anything Big Pharma developsthe green light. Essentially, danger-ous drugs are given a rubber stamp of



approval—the necessary go-ahead tomake obscene profits while killingand injuring hundreds of thousandsof people every year. It is, quite sim-ply, inexcusable. The mainstream me-dia has a lot to answer for as well, astheir lack of reporting on these issuescontributes to the problem by keep-ing a lid on reality.


“FDA's response to most expectedrisks is to deny them and wait untilthere is irrefutable evidence post-marketing, and then simply add awatered down warning in the label-



ing. In fact, when patients exhibitdrug toxicity, it is usually attrib-uted to an underlying conditionwhich we know is likely to make thedrug toxicity worse. This also al-lows the toxicity to be dismissed asbeing unrelated to the drug in anyway.

Consequently, toxicities are onlyattributed to the drug when the evi-dence is irrefutable. Thus the major-ity of cases where there is a con-tributing factor are simply dis-missed. When you do raise potentialsafety issues, the refrain that I heardrepeatedly from upper management



was‚"where are the dead bodies inthe street?" Which I took to meanthat we only do something if thepress is making an issue of it.”

FDA Safety Reviewers Made to Fearfor Their Lives?

Kavanagh was not surprised to learnabout the agency’s retaliation againstthe five whistleblowers, giving sever-al examples of how he was personallyintimidated, to the point of fearing forhis life, and the safety of his children!

“After FDA management learned Ihad gone to Congress about certain



issues, I found my office had beenentered and my computer physicallytampered with,” Kavanagh tellsRosenberg.

“... After I gave RepresentativeWaxman's (D-CA) office a USBdrive with evidence, FDA staff wasadmonished that it was prohibited todownload information to USB dri-ves. Then, after I openly reportedirregularities in an antipsychoticdrug review and FDA financial col-lusion with outsiders to SenatorGrassley’s office and the HouseCommittee on Oversight and Gov-ernment Reform, I was threatened



with prison if I should release tradesecret information to Congress...[T]he Food Drug and Cosmetics Actexplicitly allows communication oftrade secrets by FDA employees toCongress, but since most people areunaware of this, FDA managementcan use the threat of jail for viola-tion of the Trade Secrets Act, notonly to discourage reviewers, but inmy case they got Senator Grassley'sstaff to destroy the evidence I pro-vided them.

The threats, however, can be muchworse than prison. One managerthreatened my children - who had



just turned 4 and 7 years old - andin one large staff meeting, I was re-ferred to as a "saboteur." Based onother things that happened and weresaid, I was afraid that I could bekilled for talking to Congress andcriminal investigators.”

We Now Know What Domestic Sur-veillance of Whistleblowers LooksLike

The following video features attor-ney, Stephen Kohn, executive directorof the National Whistleblowers Cen-ter and attorney for the FDA whistle-



blowers in the recently revealed FDAspy operation against them.

"For the first time, we now have aglimpse into what domestic surveil-lance of whistleblowers looks like inthis country with the modern tech-nological developments," Kohnsays. "The agency [sought] to de-stroy the reputation of these whistle-blowers forever."

FDA Failures Place Health of Ameri-cans and Nation at Grave Risk

The FDA’s mission statement reads asfollows:



“The FDA is responsible for protect-ing the public health by assuring thesafety, efficacy, and security of hu-man and veterinary drugs, biologi-cal products, medical devices, ournation’s food supply, cosmetics, andproducts that emit radiation. TheFDA is also responsible for advanc-ing the public health by helping tospeed innovations that make medi-cines and foods more effective, safer,and more affordable; and helping thepublic get the accurate, science-based information they need to usemedicines and foods to improvetheir health.”



In 2007, a report bearing the revealingtitle “FDA Science and Mission atRisk” by the Subcommittee on Sci-ence and Technology, detailed howthe FDA cannot fulfill its stated mis-sion because:

1. Its scientific base has eroded andits scientific organizational struc-ture is weak

2. Its scientific workforce does nothave sufficient capacity and capa-bility, and

3. Its information technology (IT) in-frastructure is inadequate

Furthermore, the report found that



“the development of medical prod-ucts based on “new science” cannotbe adequately regulated by the FDA,and that the agency does not have thecapacity to carry out risk assessmentand analysis. Additionally, theagency’s science agenda “lacks coher-ent structure and vision, as well as ef-fective coordination and prioritiza-tion.”

The fact that the FDA does not haveits ducks in a row; has sorely mis-placed its priorities; and is not work-ing to fulfill its mission is clearly evi-denced in the numerous cases wherehundreds and sometimes thousands



of complaints about dangerous drugs(like Vioxx and Avandia), vaccines(like Gardasil), and additives (like as-partame) are stubbornly ignored,while SWAT-style teams armed to theteeth are sent to raid supplementmakers, whole food businesses, or-ganic farmers, and raw dairies whenoftentimes not a single incidence ofharm can be attributed to their prod-ucts.

According to the Science and Tech-nology Subcommittee’s report, thefailures of the FDA is placing thehealth of Americans, and indeed theeconomic health of the entire nation,



at grave risk:

“The FDA constitutes a criticalcomponent of our nation’s health-care delivery and public health sys-tem. The FDA, as much as any pub-lic or private sector institution inthis country, touches the lives,health and wellbeing of all Ameri-cans and is integral to the nation’seconomy and its security.

The FDA’s responsibilities for pro-tecting the health of Americans arefar-reaching. The FDA protects ournation’s food supply through regu-latory activities designed to cover 80



percent of the food consumed in thiscountry. The FDA also regulates alldrugs, human vaccines, and medicaldevices, and hence plays a criticalrole in ensuring the appropriatesafety and efficacy of rapidly emerg-ing medical products.

... The FDA is also central to theeconomic health of the nation, regu-lating approximately $1 trillion inconsumer products or 25 cents ofevery consumer dollar expended inthis country annually.. Thus, thenation is at risk if FDA scienceis at risk. The Subcommittee con-cluded that science at the FDA is in



a precarious position: the Agencysuffers from serious scientific defi-ciencies and is not positioned tomeet current or emerging regulato-ry responsibilities.”

Final Thoughts

One of the root causes for their utterabandonment of public safety is thatthe majority of the FDA’s fundingcomes from the very companies thatit is seeking to monitor and evaluate.The FDA has progressively morphedinto a mere pawn and instrument ofthe drug industry, which has little todo with drug safety, and everything



to do with maximizing profits.

As Dr. David Graham—anotherprominent FDA whistleblower whoblew the lid on the Vioxx scandal—stated in a 2005 interview:

“As currently configured, the FDAis not able to adequately protect theAmerican public. It's more interest-ed in protecting the interests of in-dustry. It views industry as itsclient, and the client is someonewhose interest you represent. Un-fortunately, that is the way the FDAis currently structured.

http://articles.mercola.com/sites/articles/archive/2005/08/13/secrets-of-the-fda-revealed-by-top-insider-doctor.aspx



Within the Center for Drug Evalua-tion and Research, about 80 percentof the resources are geared towardsthe approval of new drugs and 20percent is for everything else. Drugsafety is about 5 percent. The "goril-la in the living room" is new drugsand approval. Congress has not onlycreated that structure, they havealso worsened that structurethrough the PDUFA, the Prescrip-tion Drug User Fee Act, by whichdrug companies pay money to theFDA so they will review and ap-prove its drug.”

The only real solution isn't minor



changes to the existing structure, buta complete reform of the FDA. Butuntil then, please, don't risk yourmoney or your life on a paradigm de-signed to profit from your ill health.Instead, switch to natural methodsthat will allow your body to heal it-self without the need for the deadlydrugs being pushed on you by thedrug companies and the FDA.

how the fda is recklessly abandoning drug safety

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