FDA: Another Government Regulatory Disaster -- II of III

When the FDA grants approval on products marketed to consumers, the vast majority of Americans feel comfortable that the agency has performed its due diligence and the risk of injury or harm is non-existent.

Since its inception in 1906 as the Bureau of Chemistry, however, the FDA has been mired in an incestuous conflict-of-interest culture. Despite horrific reports on approved drugs harming and killing thousands of Americans, the public at large remains unaware of the agency's corrupt history.

According to its mission statement, "the FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."

While operating under the illusion of a government regulatory agency responsible for ensuring products are safe, time and time again we have witnessed the FDA acting as an agency that has abandoned the public's interest and under the control of the very industries it is charged with regulating.

Over the past thirty years, there have been countless articles and books detailing startling revelations about the pervasive influence of industry on the regulatory process and exasperating attempts to change the strangle-hold that corporations have on the FDA.

Following three frustrating years as FDA Commissioner, Dr. Herbert Lay resigned and told the San Francisco Chronicle, "The thing that bugs me is that people think the FDA is protecting them. It isn't. What the FDA is doing and what the public thinks it's doing are as different as night and day" (January 2, 1970).

In a Wall Street Journal article, "Drug Firms Use Financial Clout to Push Industry Agenda at FDA" (Sept. 1, 2006), Anna Wilde-Mathews summarized how a heavily lobbied Congress allowed industry to seize more control over the under-funded agency.

Regulators usually don't negotiate their budgets with the industries they oversee... For most of its history, the FDA was funded entirely by Congress. But in the early 1990s, companies unhappy with the pace of drug approvals agreed to pay the FDA millions of dollars in 'annual fees to help speed its performance. Because the industry and the agency renegotiate every five years over the size of fees - and what they,' can be used for - drug makers can have considerable input, into which programs receive funding. Each time the arrangement has been renewed, the FDA has gained new funding. In return, industry has wrung concessions. In the 1997 deal, the review time for a standard application dropped from 12 months to 10 months. In 2002, the FDA agreed to a number of changes, including a new deadline for how fast the agency would respond to companies' requests for meetings about their drug applications.

And herein lies the problem. We have a government that sees nothing wrong with this meddling and is apparently incapable of correcting it. As if this insidious collaborative arrangement weren't bad enough, when well-intentioned FDA scientists attempt to bring safety concerns to the attention of their superiors, they are threatened and told to keep silent or worse, change their recommendations.

It would be impossible to chronicle the sordid history of collusion and corruption of the nation's premier regulatory agency. But a re-examination seems warranted in light of the FDA's recent declaration that bisphenol A (BPA) is "safe."

Although consumer watchdog organizations have always been critical of industry influence over government agencies and the "revolving door" relationship between the two, most Americans were not aware of the serious and systemic problems plaguing the FDA until 2003. This is when newspapers around the country reported that an FDA drug safety analyst, Dr. Andrew Mosholder, warned his superiors that children taking antidepressants like Paxil and Zoloft increased their risk of becoming suicidal.

When the Senate Finance Committee and the House Energy and Commerce Subcommittee on Oversight and Investigations began to hold hearings on Mosholder revelations, drug company executives began pointing the finger back at FDA officials and blaming them for withholding information from physicians and patients. A safe thing to do, since neither are held
accountable.

("FDA Urged Withholding Data on Antidepressants," Washington Post, Sept. 10, 2004). http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9.html

According to an article published in the Washington Post:

Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels, and in one case the agency reversed a manufacturer's decision to amend its drug label to say that the drug was associated in studies with increased hostility and suicidal thinking among children... More than two-thirds of all studies of antidepressant use among depressed children have failed to show the drugs are effective.

By the end of 2004, criticism of the FDA intensified both in Congress and in the press.

In dramatic testimony before the U.S. Senate Finance Committee, Dr. David Graham, a senior official in the FDA's Office of Drug Safety, described the FDA as a "profound regulatory failure." In an illuminating and disturbing interview with PBS, Dr. Graham repeated some of what he told the Senate Committee. The scientist turned government whistle-blower explained how he was pressured by his superiors to change the conclusions of his study that found 30,000 to 55,000 deaths caused by Vioxx, Merck's blockbuster arthritis drug. When Graham refused, FDA officials withheld the public release of the full text but shared it with Merck.

"You have an agency that was completely oblivious to safety, completely insensitive to safety, that basically was willing to tolerate a 500% increased risk of heart attack with no demonstrable counter balancing benefit for the drug because it suits their clients to allow the drug to be marketed in America."

When asked, "who is the FDA working for?" Graham replied, "A former manager of mine from the Office of Drug Safety told me that industry was our client. And when I said to him, 'No, the public is my client' he said, I was wrong and it was industry."

"I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless," said Dr. Graham.

After reviewing the Vioxx clinical trials, Dr. Richard Horton, editor of The Lancet, wrote a scathing article accusing Merck and the FDA "acted out of ruthless, shortsighted and irresponsible self-interest."

The Vioxx scandal outraged the scientific and medical community, members of Congress and the public, which brought greater scrutiny on the FDA but not much of anything else. If you think anything has changed after Dr. Graham exposed the dirty dealings within the walls of the FDA and the antidepressant and Vioxx investigations, think again.

In September 2005, citing "unwarranted interference in agency decision making" on the part of then Commissioner Lester Crawford, Susan F. Wood, assistant FDA commissioner for women's health and director of the Office of Women's Health, resigned from the position she had held for five years. In an email to FDA staff, Dr. Wood said, "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."

Soon after Wood's exit, Dr. Crawford abruptly resigned as FDA Commissioner after the Wall Street Journal disclosed his stock ownership in companies regulated by the agency. Crawford later plead guilty to the conflict-of-interest charges.

Following Crawford's plea, Mike Adams, long time FDA critic and author of "Grocery Warning," told reporters, "Crawford's guilty plea now establishes as indisputable fact what myself and other FDA critics have been saying for years. The agency is headed by white-collar criminals who deliberately make regulatory decisions that are in the best interests of drug companies, junk food giants, rather than protecting the health of the public."

It is no secret that industry-funded studies were used for decades to hide the damaging affects caused by asbestos, tobacco, and lead. It is no secret that industry spends millions every year to make sure their interests are protected - at the FDA, other federal agencies and in the halls of Congress.

Whether we are talking about food, chemical or drug safety, FDA officials routinely rely upon industry-funded research as the convenient excuse for not taking action on dangerous products when safety concerns arise. This is called creating "scientific uncertainty," and has proven quite successful in thwarting regulatory action.

For years, Senator Chuck Grassley (R-IA) has been one of the FDA's harshest critics and a leader in pressing for FDA reforms, transparency and accountability. Having served as chairman of the Senate Finance Committee during the Vioxx and antidepressants hearings, Grassley began investigating the approval of the antibiotic drug Ketek after learning the drug was approved even though the agency knew "safety tests on the drug had been forged." Manufactured by Sanofi-Aventis SA, Ketek was linked to 12 cases of liver failure including four deaths.

In a press release, Grassley said, "The allegations of misconduct in this [Ketek] case are as bad as I've heard yet. It looks like the FDA caught the drug company red-handed and let them get away with it. On top of that, the FDA failed to set the record straight and, in fact, continues to cite a discredited safety study as a principle reason to feel okay about using this drug."

ABC News later reported Grassley "was sent home empty-handed" by FDA officials "who refused the powerful Republican access to information" and "wanted to speak to the FDA investigator who uncovered the fraud" about Ketek's approval.

"The study with the forged test results was conducted at a former weight loss clinic in Gadsden, Alabama. Dr. Maria Anne Kirkman-Campbell is serving five years in prison for falsifying safety test results on Ketek."

"A former nurse, Michelle Snedeker, told ABC News she was ordered to forge documents and report data on people who had not even been given Ketek. The doctor was paid $400 for each of the 407 subjects that she enrolled for the study."

As Grassley pressed for the denied documents, a defiant Dr. Andrew von Eschenbach, acting director of the FDA, refused to provide the information to the Senate Committee on Finance.

So much for the power of congressional oversight.

On February 12, 2007, the FDA finally announced that Ketek would get a "black box" warning. "The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis -- from the drug's label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications." The warning also states that "Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness."

Years later The New England Journal of Medicine published an article written by a former FDA physician, David B. Ross, M.D., Ph.D., who participated in the Ketek review:

The review of Ketek was thus marked by pronounced departures from accepted review practices. In addition to the use of fraudulent data, the substitution of uncontrolled postmarket safety reports for controlled clinical trial data, and the acceptance of trials that could not show efficacy, there was also overt internal pressure brought to bear on FDA reviewers to alter their conclusions.

But did any of these revelations change the way the FDA evaluates internal dissent regarding safety concerns? Did congressional investigations result in the agency cleaning up its act? Did von Eschenbach's refusal to cooperate with a congressional investigation prevent him from becoming FDA Commissioner? Absolutely not.

Senior officials continue to censor and intimidate honorable scientists trying to do their jobs and committed to protecting the public.

Two years following Dr. Graham's testimony before Congress, another FDA scientist, Rosemary Johann-Liang, was reprimanded when she recommended GlaxoSmithKline's diabetes drug Avandia be given a "black box" warning label to alert physicians and consumers about its heart failure risks. Again, Johann-Liang's supervisors refused to act on her report.

"I really advocate for drug safety, and a lot of times the agency doesn't want to hear that there are problems. I think, in general, there is a culture of 'the drug is always innocent," Johann-Liang told USA Today one day before leaving her job as deputy director of the Division of Drug Risk Evaluation.

Only after the New England Journal of Medicine published a study that found patients using Avandia doubled their risk of heart failure compared to individuals not taking the drug, did FDA officials finally accept Dr. Johann-Liang's report and give the drug the strongest "black box" warning label. By that time, the drug had already been prescribed for millions of Americans.

In a speech on the senate floor, Senator Grassley told his colleagues that as many as 20 heart attacks a day might be caused by Avandia. Grassley has been angry and frustrated by the attitude and actions of senior FDA officials and has introduced legislation aimed at establishing an independent drug safety review board.

In reality, the last thing industry wants is FDA reform... unless it is on their terms. And this is where all the lobbyists and campaign contributions are most effective. The political influence of the dirty money bestowed on lawmakers, partnered with industry's bankrolling of the FDA from user fees, has led to catastrophic consequences to hundreds of thousands of Americans.

In response to on-going congressional attacks, FDA officials blame a myriad of agency failures on the lack of funding. But the problems at the FDA are not because of lack of money. Good scientists like Andrew Mosholder, David Graham, and Rosemary Johann-Liang were doing their jobs and reporting safety concerns to their superiors. Warnings could have saved thousands of lives. The problem is a lack of accountability and conscience in the FDA hierarchy who so casually turn a blind eye to dangerous and deadly drugs, chemicals and food products.

When large financial institutions fail, people lose their investments. But when the FDA fails, people lose their lives. Children lose parents. Parents lose their children. Had Dr. Graham not come forward, it is very probable the FDA would still be telling Americans Vioxx is "safe," just as they are now proclaiming BPA "safe," and the arthritis drug would still be on the market, quietly injuring and killing tens of thousands of unsuspecting Americans.

Federal officials who intentionally deceive the public and mislead physicians through the illegal practice of hiding data that shows children taking antidepressants have a greater risk of committing suicide, because they are concerned that the public would lose confidence in antidepressants are not regulators are criminals. They should be treated as such.

Besides a complete overhaul, a few prosecutions might be just the medicine the FDA needs.

Comments

[balancedimmunehealth]

It is somewhat amazing how pharma is coddled while natural, quality-manufactured supplements are not allowed to plainly talk about their benefits on health conditions. If people could read on the labels how various supplements can impact health conditions from cardio to immune health to joint and cognitive health, our nation would be much further down the road in preventive health innovation. There is great data out there on nutrition and health conditions, but much of it is shielded from retail consumers.

[Doug Bremner - Huffpost Blogger]

Nice essay. May I reiterate the last comment that the biggest threat facing Americans now in this area is PREEMPTION. Simply put that is the doctrine that if the FDA approves a drug that citizens have no recourse in a court of law if they are harmed by the drug. People from Michigan have been struggling under this law for the past decade, and those who took Vioxx since 2000 (after the data showed it caused heart attacks, but before FDA acted or warnings were put in place) and suffered heart attacks had NO RECOURSE. No coming before the Supreme Court is Levine v. Wyeth where preemption threatens to become the law of the land.
http://www.huffingtonpost.com/doug-bremner/no-redemption-for-preempt_b_124227.html
As a physician and concerned citizen I urge all of you to sign the petition on ipetition.com against preemption.

As for antidepressants and suicide, the FDA actually prevented Dr. Mosholder from attending the advisory meeting on antidepressants to the FDA.

Let me add another drug disaster story to your list: 1500 children born with birth defects to mothers on the acne drug Accutane, all could have been prevented.
http://www.huffingtonpost.com/doug-bremner/health-news-you-wont-read_b_130213.html

[Hgharms]

Dr. Bremner I just read your article on PREEMPTION and could not agree more with your comments, dare I say outrage. Physicians are lured by the youthful energy of drug company sales representatives courting their bottom line while handsomely paid lobbyists doggedly trail politicians and the public fall prey to the media depictions of sexual pleasure while submerged in conspicuously placed bathtubs. This folly plays out at the expense of public health, as well the financial viability of families. Preemtively limiting recovery from harm resulting from FDA approved drugs and medical devices undermines the principles of free market by giving manufacturers and their insurers the protection of producing inferior products with the courts blessing. Meanwhile those whom have endured harm are financially strapped and not even thrown a life line. The proposed bailout for the failures of the financial market is akin to the preemptive protection afforded the drug companies.

[Daisy940]

Dr. Bremner is so right about PREEMPTION. Mercury poisoned from the dental amalgams has caused severe neurological damage that has left me in a wheelchair.The countless amounts of monies needed to restore some of my health continues to be astronomical. The FDA will not pay for this. The entire scenario with what the FDA has done and will continue to do until they are held accountable is a travesty to the American public. This is the same as what is now happening in the financial sector. What happened to honesty and accountabality? Regarding mercury dental amalgams the classification needs to be a Class III ONLY. The manufactures of amalgam NEED to prove amalgam safety and can only do this when a Class III is assigned by the FDA. It's long over due and the amalgam manufactures need to be held accountable as well as the government, politicians, lobbyists, pharmaceutical companies, etc. They need to own up to the decisions they make.

[mychris52]

One other issue that has not been raised is the legislation that Big Pharma is pushing to insulate them from law suits. Their postion is that if the FDA approves a drug that it is prima facia evidence that is safe, and therefore any resulting adverse effects cannot be attributed to the drug company.

[stickball]

Your absolutely right. Please dont buy the McCain Palin change ,it will just be more of the same and that is simply not acceptable !!

[nanton29]

Good Job Deirdre and keep on educating us on the importance of greening the cleaning.

[Hgharms]

Queen1, you could not be more correct in suggesting that each of us has the authority over our decisions and we should excercise prudent judgement. However, what makes the situation regarding the FDA so egregious, particularly regarding dental care is that insurance benefits are limited to what is usual and customary. That is of course if one has insurance. Coverage for non-mercury fillings is not provided by carriers. The greater insult is to those on governmental insurance where treatment is even more restrictive. Another problem is the exposure medical and dental students get regarding the understanding and truth about mercury fillings. The problem of industry control and influence over the FDA has directly affected the health of Americans and options of healthcare. Healthcare coverage defines the latitude of choice. Unless one can financially sustain the costs of integrative care and non-mercury options the FDA bears heavily on healthcare outcomes for many.

[Queen1]

Perhaps all of you should remember one more thing: No one forces you to take a drug. It is all optional. Take a peek at Bill Whittle's piece on having a kidney stone over at National Review Online (if you dare to read the opposition). Then remember, next time you are in agonizing pain or so stiff you can't move a joint and you pop a pill and it all gets better--no one owes you that mercy. One way to be sure you don't get hurt by a medication's side effects? Don't take any.

[OdaNobunaga]

I've known the FDA has been corrupted for years now. I'm glad someone else is trying to bring attention to this epic BS. Thank you very much.

[Hgharms]

Of great concern to anyone with "silver" fillings, aside from them consisiting of 50% mercury is the FDA's lack of action to do its job of classifing these fillings. A thorough review of dental amalgam (silver fillings) would indeed reveal the horrors of adverse health effects and environmental damage that is caused by implanting mercury into teeth. Does it make sense that one of the most toxic neurotoxins is placed into the teeth of young children and pregnant women? The body burden of this exposure is great and unmeasured by the FDA. At what point have any of the readers been asked by a dentist or their physician about their mercury level, by way of number of fillings or even dietary habits? The FDA offers no guidance on thresholds for this exposure and most doctors do not think to ask about mercury from dental exposures because they've been trained to think otherwise. Does this make sense? Mercury is being released from dental offices into waste streams and water resources and the FDA has not conducted an environmental review. Does this make sense? The FDA has deferred in great part to the input of a trade organization, American Dental Association (ADA) that has influenced much of the horrific outcome of implanting mercury into people's bodies. Shielding poor decsion making with protections like preemption is yet another discouraging outcome for the public.

[zigzag1]

Great comment Isolated...Thank you for an experienced and educated comment. As a retired pharmacist, I have suspected much of what you describe is happening. I am also very concerned that scientific journals seem to be publishing bought and paid for studies.

[KRayRPh]

Zigzag1...... I, too, am a retired pharmacist; I feel your pain!! Follow the money!

[zigzag1]

Another result of the Ronald Reagan Regulatory Irresponsibilty

[jackwaddington]

The government by it's nature is a regulatory body. It regulates who can and can't steal, who can and can't murder, who can and who can't have sex and how and where we can travel and what we can ingest or smoke. Cut ALL regulation or go into total dictatorship and make almost everything illegal. The dys of Law, Goverment and money are on their last legs. Let it go. Yeah yeah yeah everyone is scared but I say we are anticipating a scary scenario, which I predict, will not happen. A new mind set will settle in and a new manner of dealing with life will then transpire and then we will all wonder why the hell we never thought of this before.

[jcmae]

I am so glad you wrote this very thorough article on the
FDA. The comparison you make to what is happening
with the present financial disaster due to bad Government
regulation to what is going to inevitably also occur as
a medical disaster due to bad FDA regulation is apt.
Unfortunately, the dispersed nationwide, and over months
time deaths of people does not speak as poignantly to
our society's short memory as much as large sums of
money lost on Wall Street in one day. I hope people
really start waking up to the damage done to our health
by this unholy marriage between the FDA and Big Pharma.

[crokeadv]

"Deregulation" over the past 8 years has produced so much suffering. The economy, the environment, a failed energy policy. It truly boggles the mind. And nowhere is the damage more insidious than in the (non) regulation of the drug companies. Shredding the controls has produced results not unlike those produced by letting the oil companies regulate temselves. Disastrous. Except with the drug companies, peoples' heallth (and lives) are at risk. Not just their wallets. I believe the full extent of what these drug companies have wrought will not be known for years. What we've seen so far is just the tip of the iceberg. Meantime, huge advertising budgets and grossly exaggerated claims have produced dramatic increases in pill use across the board, but particularly among the young. Though it would be easy to lay this mess at the doorsteps of "big pharma", those guys are in BUSINESS. They go to the office everyday to make money for their stockholders. No, I lay the blame at the feet of George W. Bush and Dick Cheney, the architects of the failed policies of these past 8 years. By the way, for the BEST analysis of the impact (and underlying reasons for) of deregulation of "big pharma" on this country, read Melody Peterson's new book, "OUR DAILY MEDS". She absolutely nails it. Thanks, Deirdre, for working so hard to get the truth out. We need this kind of journalism, now more than ever before. Bill Croke/ /Martha's Vineyard, MA

[changeneeded]

We seriously need change and we need it now! Our govenment is out of control. We the people are NOT in control of our own government. Far too many of our elected officials who are supposed to be doing our bidding, pay no attention to us and pay attention only to what benefits them. All these government agencies that are supposed to be protecting us, are only protecting the profits of big business We the People, need to take our country back. We the People need to take control over the future of this once great country of ours. We need to hold our elected officials accountable when they do not do what they say they are going to do or act contrary to the voices of their constituants. Each and every American had darned well better wake up and take notice of what is happening and start making their voices heard at the polls this November and then continue to make their voices heard until our nation makes the necessary turn around needed to restore us to our former respectable power.

The FDA is all about big business and profits. All government agencies are operating for the benefit of big business and profit. It's not working. It's now or never people. Now or never.

[ProgressiveVoice]

Right on, changeneeded! Everything you have said has been what I have been saying - of course I agree!
It occurred to me yesterday - sure, lobbyists dump millions of dollars for industry on politicians and it does have an effect. They still need the People though - industry can't provide enough VOTES, just money. They don't even care who it goes to, not really. Look how many of McCain's donors are also Obama's (great lists on Hightower Lowdown site). I am not saying that all that money doesn't make a difference because it does. However, next time you hear someone ask what difference does their one vote make, you can tell them, it only doesn't make a difference if you DO NOT VOTE.
(Unless, of course, they start sending lobbyists door-to-door. They can buy my vote but they will have to fork over a couple of million to do so. Don't let them buy YOU for less)