Fwd: Obama Calls for FDA Review: Issues That He Should Consider Examining

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org and http://ahrp.blogspot.com FYIIn an interview on NBC Today show, Feb 2, 2009, President Obama indicatedthat he is ordering a "complete review" of the Food and Drug Administrationafter it failed to detect shipments of salmonella-contaminated peanutproducts that have sickened more than 500 people and may be linked to asmany as eight deaths."At a bare minimum, we should be able to count on our government keeping ourkids safe when they eat peanut butter," the president said."That's what Sasha eats for lunch," President Obama said, referring to his7-year-old daughter. "Probably three times a week. I don't want to worryabout whether she's going to get sick as a consequence of eating her lunch."Beyond food processing--which is of vital importance--the following FDApolicies and processes need an independent thorough assessment, followed bythe appointment of a new leadership to implement much needed reforms:1. FDA's hasty reversal of a regulatory prohibition against off-labelpromotion of prescription drugs. This change, widely seen as a gift to the pharmaceutical industry, wasauthorized during the last days of the Bush Administration. To appreciate the $$ value of FDA's "gift" to industry one need only look atthe costs companies absorb in legal fees, civil liability, coupled withcriminal suits by the Department of Justice--for off-label promotion. Just this month, Eli Lilly pled guilty to criminal marketing of Zyprexa foroff-label uses, settling for $1.4 billion. The FDA stood idly by as Lillyembarked on a Zyprexa marketing blitz --"Viva Zyprexa"-- misleadingphysicians and the public with false claims about its efficacy and safety.http://blogs.wsj.com/health/2009/01/15/justice-department-beats-chest-over-zyprexa-settlement/   Similar suits against Pfizer for off-label marketing of Bextra and Celebrexwill cost the company $2.3 billion.http://blogs.wsj.com/health/2009/01/26/pfizer-takes-23-billion-charge-linked-to-bextra-probe/   2. The FDA has failed to carry out due diligence--as mandated by law--toprotect the public from unsafe drugs and medical devices. Federal lawrequires manufacturers to prove safety and effectiveness "with substantialevidence through the conduct of well controlled trials" before marketinglicensure is granted. Furthermore, FDA's mission requires the agency to help"the public get the accurate, science-based information they need to usemedicines and foods to improve their health."FDA officials fail to implement federal law. FDA has been severely criticized for its minimal post-marketing drug safetyassessment coupled with minimal inspections of manufacturing plants. FDA'sfailures are measurable in the number of patients being harmed by defectiveor inadequately tested drugs and devices. Most are approved without labelwarnings.  Below,  three current case examples encapsulate a failed regulatoryenvironment under the current FDA administration that has led to theperversion of "evidence-based medicine." They provide but a glimpse into thetip of a hidden iceberg. The truth is, Americans can no longer rely on thesafety of drugs their doctor prescribes because the FDA has given marketingapproval to both patented and generic prescription drugs that are shown toincrease the risk of death. 3. FDA's hands-off policy--its failure to intervene when companies makefalse claims about a drug's safety and efficacy-- allows medical practice tobe dictated by manufacturers' business interests-even if they underminepublic health.  That hands-off policy costs the American taxpayer billionsof dollars not only for ineffective drugs, but the high cost of treatmentsto counteract drug-induced chronic diseases.   In part, FDA's failure to monitor serious adverse drug event reports stemsfrom an inherent conflict of interest within the agency. Officials of the Center for Drug Evaluation and Research (CDER) whorecommended a drug's approval for marketing are invested in NOTacknowledging they erred, even when the drug-related injuries and deathsmount.  CDER officials wear both hats while the drug safety officers arerelegated to the sidelines.4. Conflicts of interest introduce biased safety / efficacy analyses andbiased claimed findings.FDA's drug evaluation process has led to the approval of unsafe, ineffectivedrugs on the basis of scientifically flawed trials.  The latest is a report by The Office of Inspector General (Jan. 2009) whichfound: "the Food and Drug Administration does almost nothing to police thefinancial conflicts of doctors who conduct clinical trials of drugs andmedical devices in human subjects." Furthermore,  the investigators say,"agency officials told them that trying to protect patients from suchconflicts was not worth the effort."http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf  In January 2009, The New York Times reported that internal documents confirmthat FDA's approval process has been corrupted by political influencepeddling. http://www.nytimes.com/2009/01/13/health/policy/13fda.html5. FDA's preemption position, adopted during the Bush Administration, is aradical departure from FDA's longstanding policy--and should be rejected.By invoking the argument of preemption, manufacturers are shielded fromproduct liability suits--no matter what the defect. That policy not onlyprevents citizens from seeking just compensation for harm caused bydefective drugs and devices, but the policy encourages manufacturers to cutcorners, sacrificing safety for increased profits.Fairness and justice aside,  the body of evidence documenting FDA'sdemonstrable incapacity to protect the public from unsafe drugs and devicesspeaks for itself. No reasonable argument can be made to claim that FDAapproval is sufficient to warrant preemption of all state product safetylaws.THREE CURRENT EXAMPLES encapsulate a failed regulatory environment. FDAofficials do little to ensure drug safety by failing to implement federallaw requiring manufacturers to prove safety and effectiveness "withsubstantial evidence through the conduct of well controlled trials" beforemarketing licensure is granted. Instead, FDA officials rationalize and bends over backwards to approve drugswhose manufacturers have not proven safety and effectiveness. 1. After years of controversy, the FDA has finally called upon Eli Lilly toconduct safety trials for its controversial drug, Xigris, for the treatmentof sepsis. http://www.fda.gov/medwatch/safety/2009/safety09.htm#Xigris FDA approved the drug despite a split vote (10 to 10) of the advisorycommittee, due to concerns about the validity of the claimed efficacy andsafety findings. http://www.fda.gov/ohrms/dockets/ac/01/minutes/3797m1.pdfFDA's current hands-off policy has led companies to disseminate dubiousmarketing claims under the mantle of "science-based" authority in practiceguidelines: Indeed, clinical guidelines for the treatment of sepsis were orchestrated asan extension of Eli Lilly's  "Surviving Sepsis" marketing campaign.  WhereasLilly proclaimed: "Xigris offers safe and effective treatment so moresurvive." FDA officials knew that the scientific evidence shows the oppositeto be true.See: Vioxx Redux - FDA on Sidelines as Marketing Subsumes Evidence:Surviving Sepsis (NEJM)http://ahrp.blogspot.com/2006/10/vioxx-redux-fda-on-sidelines-as.htmlThe latest study, published in the current issue of Critical Care Medicine,confirmed that patients prescribed Xigris have an increased risk of death.[1] 2. The FDA has been negligent when it failed to inform physicians and thepublic--in some cases for decades--about the suicide risk linked to numerousprescribed drugs--including drugs prescribed for non-psychiatric conditions.These include: - Singulair (prescribed for asthma) - SSRI antidepressants(including Paxil, Prozac, Zoloft, Effexor, Cymbalta) - Chantix (prescribedfor smoking cessation) - Tamiflu (anti-flu) - Accutane (prescribed for acne)- Epilepsy drugs (including carbamazepine, gabapentin, felbamate,lamotrigine, levetiracetam, oxcarbazepine, pregabalin and valproate) FDA officials have consistently downplayed the risks when independentanalysts who examined FDA's MedWatch database, reported a significantsuicide risk. For example, FDA's latest Drug Safety Newsletter comparesreports of suicidality for Chantix and Zyban / Wellbutrin prescribed againstsmoking.http://www.fda.gov/cder/dsn/2009_v2_no1/DSN_Vol2Num1.pdfFDA's presentation of the data would suggest the risk for Chantix is roughlydouble the risk for Zyban:--153 reported cases of suicidality for Chantix, of which 37 were suicidescompared to -75 reported cases of suicidality for Zyban, of which 29 werecompleted suicidesHowever, that is a distortion:  The FDA compared suicide reports for bothdrugs since FDA approval for smoking cessation.Zyban was approved in May 1997--it's been on the market for 120 months (10years).Chantix was approved in May 2006--it's been on the market for just 17months. A fair comparison would be to compare the first 17 months of Zyban with thefirst 17 months for Chantix.The data shows that Chantix, with 37 reported SUICIDES in just 17 monthsposes a risk, perhaps 14 times greater than Zyban with 29 SUICIDES in 10yearsFurthermore, Chantix could be even worse.  Zyban / Wellbutrin carries a black box warning about suicidalbehavior--Chantix does not. Zyban is mostly used to treat depression, only afraction of its use is as an aid to smoking cessation.  The FDA didn't saywhether it excluded suicidality reports where the drug was indicated fordepression.3. The number of defective generic drugs has reached critical proportions:In Sept. 2008, the FDA sent a warning letter to the Indian generic druggiant Ranbaxy about its shoddy production of some 26 widely used drugs inAmerica. The list of drugs produced at two Ranbaxy plants and subject to FDA'swarning contains 26 drugs, including low-cost versions of such mainstays aspravastatin and simvastatin (commercially known as Pravachol and Zocor, usedto lower cholesterol), metformin and glimeperide (for diabetes), acyclovirand ciprofloxacin (an antiviral and antibiotic medication) and gabapentin(known as Neurontin and used for epilepsy and some psychiatric conditions).However, "the FDA says it has found no evidence that consumers have beenharmed by shoddy production standards that were observed in manufacturingthese generics at two plants in India. It's not issuing a recall, and urgespatients who take these medications to continue to take them rather thanstop without a doctor's recommendation, which could be dangerous."http://latimesblogs.latimes.com/booster_shots/2008/09/fda-issues-warn.htmlToday, a massive recall by generic manufacturer, Ethex, was issued for over60 generic drug products at the wholesale level: http://www.ethex.com/news/pdf/recall_020309.pdfhttp://www.ethex.com/news/pdf/recall_wholesale.pdfThe FDA advisory recommended "Patients who may have these medicines in theirpossession should continue to take them in accordance with theirprescriptions, as the risk of suddenly stopping needed medication may placepatients at risk. Patients should contact their physician or healthcareprovider if they have experienced any problems that may be related to takingor using these products..." If the drugs a defective what is the rationalefor recommending continued use? Wouldn't patients be better served by adviceto see their doctor at once?An exasperated physician emailed us this morning: "Our hospital has loads oftheir drugs on the shelves....When will the government say enough is enoughand really monitor this stuff and deal with things like this at an earlierstage?"Reference:Chris A. Gentry, PharmD; Kristin Busse Gross, PharmD; Bhanu Sud, MD; DouglasA. Drevets, MD Adverse outcomes associated with the use of drotrecogin alfa(activated) in patients with severe sepsis and baseline bleedingprecautions, Critical Care Medicine. 37(1):327-329, January 2009.Contact: Vera Hassner Sharavveracare212-595-8974http://pharmalittle.blogspot.com/2009/02/obama-congress-may-reverse-liberalized.html Sunday, February 1, 2009OBAMA, CONGRESS MAY REVERSE "LIBERALIZED" OFF-LABEL GUIDELINES Good-bye to the Good-bye PresentsAs most here will know, as part of their final act, the political appointeesand (most likely) some of the FDA career staff declared a change inguidelines for off-label promotion of drugs. The core of the new guidelinesis that FDA would not require prior review of the off-label promotionalmaterials when they were used for marketing to docs. The text about"peer-reviewed journals" remained.As is conventional, those proffering the guidelines said that this was onlyformalizing what was already policy. Those not inclined to agree describedthe change as one more last-ditch attempt to save the world for off-labelpromotion. Given that the past few weeks have seen the largest busts foroff-label promotion in history - both Lilly/Zyprexa and Pfizer/Bextra - addsa little irony to the development.The Fort Worth Star Telegram reports that both the administration and keymembers of Congress - particular Senator Grassley and Representative Waxman- will act to reverse the guidelines.Dare I ask: Opinions out there?     http://www.star-telegram.com/health/story/1177352.htmlTuesday, Feb 3, 2009 Obama may look at FDA's new guidelines on off-label drug marketing By CHRIS ADAMS McClatchy Newspapers CORNELIUS, N.C. - In the waning days of the Bush administration, theFood and Drug Administration finalized new guidelines to make it easier fordrug manufacturers to promote "off-label" prescription drug uses, which canbe deadly.  The move came despite criticism from then-President George W. Bush'sDepartment of Veterans Affairs, which said the change "favors businessinterests over public safety" and could lead to a "decline in drug safety."It was also crafted despite efforts by state and federal law enforcementexperts to clamp down on off-label drug marketing. The new guidelines were issued four years after Robin Briggs ofCornelius, N.C., buried her husband, Doug, who committed suicide on a chillyChristmas Day after taking a drug off-label. Doug Briggs, a physician, took the epilepsy drug Neurontin for hispersistent back pain. It didn't do much for his back, but Robin Briggs saidthe drug changed his demeanor and led to his death. Federal officials have since told Pfizer and other makers ofanti-epilepsy drugs to add suicide-risk warnings to their drugs' packaginglabels. Robin Briggs sued Pfizer and the maker of a generic version of thedrug. The case is pending. As the Obama administration reviews all the rules that the departingBush administration issued, it will have to decide whether to try to modifyor reverse this last-minute change in the FDA's oversight of off-label drugmarketing. Congressional leaders from both parties criticized the guidelinewhen it was proposed last year. Sen. Charles Grassley, an Iowa Republicanwho has repeatedly investigated the FDA, said he had serious concerns aboutthe proposal, which he said would deem appropriate something that "the FDAonce considered evidence of unlawful marketing." "A legislative fix may be in order," Grassley said Thursday. In the House of Representatives, Rep. Henry Waxman, D-Calif., calledthe guideline a "long-coveted parting gift" for the pharmaceutical industrythat "fundamentally undermines" the FDA's authority. The use of drugs "off-label" - for reasons the FDA hasn't approved -has long been tolerated and sometimes encouraged. It can be helpful forcertain ailments. But the practice can also be dangerous. Nearly every drug has sideeffects, some of them serious. Those risks can be worth the potentialbenefit that comes with an FDA-approved, on-label use. With an off-labeluse, however, the risks remain but the benefits are far less certain. While it's legal for physicians to prescribe drugs off-label - oftenbased on their reading of the latest medical research - it's illegal fordrugmakers to push such uses. Over the past five years, federal prosecutors and state attorneysgeneral have brought more than a dozen cases against drugmakers foroff-label marketing and won more than $6 billion in criminal and civilsettlements, according to the Government Accountability Office and theDepartment of Justice. In January, two of the nation's largest drugmakers, Pfizer and EliLilly and Co., said they'd agreed to two of the biggest off-labelsettlements ever. "The FDA has been abysmal policing this area," said ConnecticutAttorney General Richard Blumenthal, who helped engineer a major off-labelcase against drugmaker Cephalon. "One reason the states have been more andmore active is that the federal government has been asleep at the switch." In its final week, the Bush administration opened the door to someoff-label marketing. In what's called a "guidance" document, the FDAspecified how drug companies could hand out medical journal articles thathighlight potential off-label drug uses. The guidance was complicated, and the main players in the issuestill disagree about what it means for FDA oversight of off-label marketing.FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

[Guest guest]

If Obama can dismantle the FDA I will personally declare him the most courageous pres of my long lifetime. His presidency will be declared a success no matter how many errors in judgement he makes on other subjects.--- On Wed, 2/4/09, Viviane Lerner <vivlerner wrote:

Viviane Lerner <vivlerner Fwd: Obama Calls for FDA Review: Issues That He Should Consider Examining"HEALTH & HEALING" Cc: "ALTERNET" <joshua.holland, "PROGRESSIVE REVIEW" <newsWednesday, February 4, 2009, 7:05 PM

 

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp. org and http://ahrp. blogspot. com

 

FYI

 

In an interview on NBC Today show, Feb 2, 2009, President Obama indicated

that he is ordering a "complete review" of the Food and Drug Administration

after it failed to detect shipments of salmonella-contamin ated peanut

products that have sickened more than 500 people and may be linked to as

many as eight deaths.

 

"At a bare minimum, we should be able to count on our government keeping our

kids safe when they eat peanut butter," the president said.

"That's what Sasha eats for lunch," President Obama said, referring to his

7-year-old daughter. "Probably three times a week. I don't want to worry

about whether she's going to get sick as a consequence of eating her lunch."

 

 

Beyond food processing-- which is of vital importance-- the following FDA

policies and processes need an independent thorough assessment, followed by

the appointment of a new leadership to implement much needed reforms:

 

1. FDA's hasty reversal of a regulatory prohibition against off-label

promotion of prescription drugs.

This change, widely seen as a gift to the pharmaceutical industry, was

authorized during the last days of the Bush Administration.

To appreciate the $$ value of FDA's "gift" to industry one need only look at

the costs companies absorb in legal fees, civil liability, coupled with

criminal suits by the Department of Justice--for off-label promotion.

 

Just this month, Eli Lilly pled guilty to criminal marketing of Zyprexa for

off-label uses, settling for $1.4 billion. The FDA stood idly by as Lilly

embarked on a Zyprexa marketing blitz --"Viva Zyprexa"-- misleading

physicians and the public with false claims about its efficacy and safety.

http://blogs. wsj.com/health/ 2009/01/15/ justice-departme nt-beats- chest-over- z

yprexa-settlement/

 

Similar suits against Pfizer for off-label marketing of Bextra and Celebrex

will cost the company $2.3 billion.

http://blogs. wsj.com/health/ 2009/01/26/ pfizer-takes- 23-billion- charge-linked

-to-bextra-probe/

 

2. The FDA has failed to carry out due diligence--as mandated by law--to

protect the public from unsafe drugs and medical devices. Federal law

requires manufacturers to prove safety and effectiveness "with substantial

evidence through the conduct of well controlled trials" before marketing

licensure is granted. Furthermore, FDA's mission requires the agency to help

"the public get the accurate, science-based information they need to use

medicines and foods to improve their health."

FDA officials fail to implement federal law.

 

FDA has been severely criticized for its minimal post-marketing drug safety

assessment coupled with minimal inspections of manufacturing plants. FDA's

failures are measurable in the number of patients being harmed by defective

or inadequately tested drugs and devices. Most are approved without label

warnings.

 

Below, three current case examples encapsulate a failed regulatory

environment under the current FDA administration that has led to the

perversion of "evidence-based medicine." They provide but a glimpse into the

tip of a hidden iceberg. The truth is, Americans can no longer rely on the

safety of drugs their doctor prescribes because the FDA has given marketing

approval to both patented and generic prescription drugs that are shown to

increase the risk of death.

 

3. FDA's hands-off policy--its failure to intervene when companies make

false claims about a drug's safety and efficacy-- allows medical practice to

be dictated by manufacturers' business interests-even if they undermine

public health. That hands-off policy costs the American taxpayer billions

of dollars not only for ineffective drugs, but the high cost of treatments

to counteract drug-induced chronic diseases.

 

In part, FDA's failure to monitor serious adverse drug event reports stems

from an inherent conflict of interest within the agency.

Officials of the Center for Drug Evaluation and Research (CDER) who

recommended a drug's approval for marketing are invested in NOT

acknowledging they erred, even when the drug-related injuries and deaths

mount. CDER officials wear both hats while the drug safety officers are

relegated to the sidelines.

 

4. Conflicts of interest introduce biased safety / efficacy analyses and

biased claimed findings.

FDA's drug evaluation process has led to the approval of unsafe, ineffective

drugs on the basis of scientifically flawed trials.

The latest is a report by The Office of Inspector General (Jan. 2009) which

found: "the Food and Drug Administration does almost nothing to police the

financial conflicts of doctors who conduct clinical trials of drugs and

medical devices in human subjects." Furthermore, the investigators say,

"agency officials told them that trying to protect patients from such

conflicts was not worth the effort."

http://www.oig. hhs.gov/oei/ reports/oei- 05-07-00730. pdf

 

In January 2009, The New York Times reported that internal documents confirm

that FDA's approval process has been corrupted by political influence

peddling.

http://www.nytimes. com/2009/ 01/13/health/ policy/13fda. html

 

5. FDA's preemption position, adopted during the Bush Administration, is a

radical departure from FDA's longstanding policy--and should be rejected.

By invoking the argument of preemption, manufacturers are shielded from

product liability suits--no matter what the defect. That policy not only

prevents citizens from seeking just compensation for harm caused by

defective drugs and devices, but the policy encourages manufacturers to cut

corners, sacrificing safety for increased profits.

 

Fairness and justice aside, the body of evidence documenting FDA's

demonstrable incapacity to protect the public from unsafe drugs and devices

speaks for itself. No reasonable argument can be made to claim that FDA

approval is sufficient to warrant preemption of all state product safety

laws.

 

THREE CURRENT EXAMPLES encapsulate a failed regulatory environment. FDA

officials do little to ensure drug safety by failing to implement federal

law requiring manufacturers to prove safety and effectiveness "with

substantial evidence through the conduct of well controlled trials" before

marketing licensure is granted.

Instead, FDA officials rationalize and bends over backwards to approve drugs

whose manufacturers have not proven safety and effectiveness.

 

1. After years of controversy, the FDA has finally called upon Eli Lilly to

conduct safety trials for its controversial drug, Xigris, for the treatment

of sepsis. http://www.fda. gov/medwatch/ safety/2009/ safety09. htm#Xigris

 

FDA approved the drug despite a split vote (10 to 10) of the advisory

committee, due to concerns about the validity of the claimed efficacy and

safety findings. http://www.fda. gov/ohrms/ dockets/ac/ 01/minutes/ 3797m1.pdf

 

FDA's current hands-off policy has led companies to disseminate dubious

marketing claims under the mantle of "science-based" authority in practice

guidelines:

Indeed, clinical guidelines for the treatment of sepsis were orchestrated as

an extension of Eli Lilly's "Surviving Sepsis" marketing campaign. Whereas

Lilly proclaimed: "Xigris offers safe and effective treatment so more

survive." FDA officials knew that the scientific evidence shows the opposite

to be true.

See: Vioxx Redux - FDA on Sidelines as Marketing Subsumes Evidence:

Surviving Sepsis (NEJM)

http://ahrp. blogspot. com/2006/ 10/vioxx- redux-fda- on-sidelines- as.html

 

The latest study, published in the current issue of Critical Care Medicine,

confirmed that patients prescribed Xigris have an increased risk of death.

[1]

 

2. The FDA has been negligent when it failed to inform physicians and the

public--in some cases for decades--about the suicide risk linked to numerous

prescribed drugs--including drugs prescribed for non-psychiatric conditions.

 

These include: - Singulair (prescribed for asthma) - SSRI antidepressants

(including Paxil, Prozac, Zoloft, Effexor, Cymbalta) - Chantix (prescribed

for smoking cessation) - Tamiflu (anti-flu) - Accutane (prescribed for acne)

- Epilepsy drugs (including carbamazepine, gabapentin, felbamate,

lamotrigine, levetiracetam, oxcarbazepine, pregabalin and valproate)

 

FDA officials have consistently downplayed the risks when independent

analysts who examined FDA's MedWatch database, reported a significant

suicide risk. For example, FDA's latest Drug Safety Newsletter compares

reports of suicidality for Chantix and Zyban / Wellbutrin prescribed against

smoking.

http://www.fda. gov/cder/ dsn/2009_ v2_no1/DSN_ Vol2Num1. pdf

 

FDA's presentation of the data would suggest the risk for Chantix is roughly

double the risk for Zyban:

--153 reported cases of suicidality for Chantix, of which 37 were suicides

compared to -75 reported cases of suicidality for Zyban, of which 29 were

completed suicides

 

However, that is a distortion: The FDA compared suicide reports for both

drugs since FDA approval for smoking cessation.

Zyban was approved in May 1997--it's been on the market for 120 months (10

years).

Chantix was approved in May 2006--it's been on the market for just 17

months.

A fair comparison would be to compare the first 17 months of Zyban with the

first 17 months for Chantix.

 

The data shows that Chantix, with 37 reported SUICIDES in just 17 months

poses a risk, perhaps 14 times greater than Zyban with 29 SUICIDES in 10

years

Furthermore, Chantix could be even worse.

Zyban / Wellbutrin carries a black box warning about suicidal

behavior--Chantix does not. Zyban is mostly used to treat depression, only a

fraction of its use is as an aid to smoking cessation. The FDA didn't say

whether it excluded suicidality reports where the drug was indicated for

depression.

 

3. The number of defective generic drugs has reached critical proportions:

In Sept. 2008, the FDA sent a warning letter to the Indian generic drug

giant Ranbaxy about its shoddy production of some 26 widely used drugs in

America.

The list of drugs produced at two Ranbaxy plants and subject to FDA's

warning contains 26 drugs, including low-cost versions of such mainstays as

pravastatin and simvastatin (commercially known as Pravachol and Zocor, used

to lower cholesterol) , metformin and glimeperide (for diabetes), acyclovir

and ciprofloxacin (an antiviral and antibiotic medication) and gabapentin

(known as Neurontin and used for epilepsy and some psychiatric conditions).

 

However, "the FDA says it has found no evidence that consumers have been

harmed by shoddy production standards that were observed in manufacturing

these generics at two plants in India. It's not issuing a recall, and urges

patients who take these medications to continue to take them rather than

stop without a doctor's recommendation, which could be dangerous."

http://latimesblogs .latimes. com/booster_ shots/2008/ 09/fda-issues- warn.html

 

Today, a massive recall by generic manufacturer, Ethex, was issued for over

60 generic drug products at the wholesale level:

http://www.ethex. com/news/ pdf/recall_ 020309.pdf

http://www.ethex. com/news/ pdf/recall_ wholesale. pdf

 

The FDA advisory recommended "Patients who may have these medicines in their

possession should continue to take them in accordance with their

prescriptions, as the risk of suddenly stopping needed medication may place

patients at risk. Patients should contact their physician or healthcare

provider if they have experienced any problems that may be related to taking

or using these products..." If the drugs a defective what is the rationale

for recommending continued use? Wouldn't patients be better served by advice

to see their doctor at once?

 

An exasperated physician emailed us this morning: "Our hospital has loads of

their drugs on the shelves....When will the government say enough is enough

and really monitor this stuff and deal with things like this at an earlier

stage?"

 

Reference:

Chris A. Gentry, PharmD; Kristin Busse Gross, PharmD; Bhanu Sud, MD; Douglas

A. Drevets, MD Adverse outcomes associated with the use of drotrecogin alfa

(activated) in patients with severe sepsis and baseline bleeding

precautions, Critical Care Medicine. 37(1):327-329, January 2009.

 

 

Contact: Vera Hassner Sharav

veracare (AT) ahrp (DOT) org

212-595-8974

 

 

http://pharmalittle .blogspot. com/2009/ 02/obama- congress- may-reverse- liberali

zed.html

Sunday, February 1, 2009

 

OBAMA, CONGRESS MAY REVERSE "LIBERALIZED" OFF-LABEL GUIDELINES

 

Good-bye to the Good-bye Presents

 

As most here will know, as part of their final act, the political appointees

and (most likely) some of the FDA career staff declared a change in

guidelines for off-label promotion of drugs. The core of the new guidelines

is that FDA would not require prior review of the off-label promotional

materials when they were used for marketing to docs. The text about

"peer-reviewed journals" remained.

 

As is conventional, those proffering the guidelines said that this was only

formalizing what was already policy. Those not inclined to agree described

the change as one more last-ditch attempt to save the world for off-label

promotion. Given that the past few weeks have seen the largest busts for

off-label promotion in history - both Lilly/Zyprexa and Pfizer/Bextra - adds

a little irony to the development.

 

The Fort Worth Star Telegram reports that both the administration and key

members of Congress - particular Senator Grassley and Representative Waxman

- will act to reverse the guidelines.

 

Dare I ask: Opinions out there?

 

 

http://www.star- telegram. com/health/ story/1177352. html

 

Tuesday, Feb 3, 2009

Obama may look at FDA's new guidelines on off-label drug marketing

By CHRIS ADAMS

McClatchy Newspapers

CORNELIUS, N.C. - In the waning days of the Bush administration, the

Food and Drug Administration finalized new guidelines to make it easier for

drug manufacturers to promote "off-label" prescription drug uses, which can

be deadly.

 

The move came despite criticism from then-President George W. Bush's

Department of Veterans Affairs, which said the change "favors business

interests over public safety" and could lead to a "decline in drug safety."

It was also crafted despite efforts by state and federal law enforcement

experts to clamp down on off-label drug marketing.

 

The new guidelines were issued four years after Robin Briggs of

Cornelius, N.C., buried her husband, Doug, who committed suicide on a chilly

Christmas Day after taking a drug off-label.

 

Doug Briggs, a physician, took the epilepsy drug Neurontin for his

persistent back pain. It didn't do much for his back, but Robin Briggs said

the drug changed his demeanor and led to his death.

 

Federal officials have since told Pfizer and other makers of

anti-epilepsy drugs to add suicide-risk warnings to their drugs' packaging

labels. Robin Briggs sued Pfizer and the maker of a generic version of the

drug. The case is pending.

 

As the Obama administration reviews all the rules that the departing

Bush administration issued, it will have to decide whether to try to modify

or reverse this last-minute change in the FDA's oversight of off-label drug

marketing.

 

Congressional leaders from both parties criticized the guideline

when it was proposed last year. Sen. Charles Grassley, an Iowa Republican

who has repeatedly investigated the FDA, said he had serious concerns about

the proposal, which he said would deem appropriate something that "the FDA

once considered evidence of unlawful marketing."

 

"A legislative fix may be in order," Grassley said Thursday.

 

In the House of Representatives, Rep. Henry Waxman, D-Calif., called

the guideline a "long-coveted parting gift" for the pharmaceutical industry

that "fundamentally undermines" the FDA's authority.

 

The use of drugs "off-label" - for reasons the FDA hasn't approved -

has long been tolerated and sometimes encouraged. It can be helpful for

certain ailments.

 

But the practice can also be dangerous. Nearly every drug has side

effects, some of them serious. Those risks can be worth the potential

benefit that comes with an FDA-approved, on-label use. With an off-label

use, however, the risks remain but the benefits are far less certain.

 

While it's legal for physicians to prescribe drugs off-label - often

based on their reading of the latest medical research - it's illegal for

drugmakers to push such uses.

 

Over the past five years, federal prosecutors and state attorneys

general have brought more than a dozen cases against drugmakers for

off-label marketing and won more than $6 billion in criminal and civil

settlements, according to the Government Accountability Office and the

Department of Justice.

 

In January, two of the nation's largest drugmakers, Pfizer and Eli

Lilly and Co., said they'd agreed to two of the biggest off-label

settlements ever.

 

"The FDA has been abysmal policing this area," said Connecticut

Attorney General Richard Blumenthal, who helped engineer a major off-label

case against drugmaker Cephalon. "One reason the states have been more and

more active is that the federal government has been asleep at the switch."

 

In its final week, the Bush administration opened the door to some

off-label marketing. In what's called a "guidance" document, the FDA

specified how drug companies could hand out medical journal articles that

highlight potential off-label drug uses.

 

The guidance was complicated, and the main players in the issue

still disagree about what it means for FDA oversight of off-label marketing.

 

 

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