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More than 1,000 studies haven’t even begun, hundreds more are incomplete, and some of the promised research has been pending for years — or simply cancelled.

As part of their approval for new products, drug makers often agree to perform additional research into safety, dosing and other concerns after the drugs come to market. The research, called a Phase IV trial, is usually voluntary, but frequently is neither officially scheduled, nor is it policed to assure completion by the FDA.

Over the past couple of years, lawmakers began making noises around Washington about the staggering numbers of incomplete studies. And in March, the Government Accountability Office (GAO), spurred by Sen. Charles Grassley (R-IA), launched an investigation into the nature of FDA drug approvals and FDA-ordered post-marketing studies.

In late April, the FDA released figures detailing the status of all the studies on its books, and the statistics are depressing, to say the least, for doctors and patients. The agency’s summary reveals that 1,044, or 62 percent, of incomplete studies for drugs and biotechs had yet to be started as of Sept. 30, 2007. A year earlier, reports Bloomberg News, 1,026, or 63 percent, of unfinished studies hadn’t yet begun. So the situation is actually worsening — we’re 1 percent better, but in total, we’re further behind.

Last September, President Bush signed the Food and Drug Administration Amendments Act (FDAAA) of 2007 into law, which allows the FDA to legally require certain post-approval studies. In fact, under the new law, the agency can fine companies up to $1 million for failing to perform those studies. Grassley argued for higher fines, and in his request to the GAO asked if the FDA needs even more authority to compel the studies.

The Pharmaceutical Research and Manufacturers of America, one of Big Pharma’s lobbying groups in Washington, responded to Bloomberg that studies can “take a long time to begin because of discussions with the FDA over how they should be conducted”, adding that enrolling patients in studies can be difficult, too. Not surprisingly, they didn’t mention that the substantial costs of many Phase IV trials may be the real reason for the delays.

And an FDA spokesperson said it is considering how to “integrate” its new power to require studies with commitments that have been made by drug makers. The FDA’s Susan Cruzan told Bloomberg that “they will work to ensure that previously promised studies are completed in a timely manner.” Just what a “timely manner” might mean is yet to be defined.

It’s been two months since the FDA released the statistics, and 10 months since the Act was signed. Pharmaceutical safety is an immense public issue, and there’s been plenty of time for the agency to start flexing its new muscles. But were still hearing double-speak from Big Pharma and the FDA.

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Debate concerns threat to medicine’s integrity by pharmaceutical, biotechnology and medical device companies’ heavy funding of many aspects of medical education.

By the time you read this, a decision may already have been reached to adopt — or reject — a proposal by the AMA’s Council on Judicial and Ethical Affairs to ban most industry funding of undergraduate, graduate, and continuing medical education.

Getting rid of Big Pharma’s influence on education, and the considerable financial pressures from device makers and biotech companies as well, is seen as an essential step for the medical profession to regain the autonomy it needs to regulate itself.

In its report, the Council says a ban on industry funding is needed to “ensure that the values and core commitments of the profession protect the integrity of professional education.”

The proposal would ban funding by Big Pharma for residency positions and clinical fellowships, and continuing educational programs including physician speakers’ bureaus and travel and lodging expenses for attendees. Gifts, meals, and pharma rep visits to med schools would also be banned.

Training in new diagnostic or therapeutic devices and techniques by industry reps would have to be excluded from the ban, the proposal says, but after that, industry involvement would be “no longer warranted.”

The AMA’s house of delegates was to decide the issue today, but we may not know the results immediately. We can only hope for a positive result, but according to Ed Silverman in his Pharmalot blog, chances are slim it will be passed.

Silverman reports that a source familiar with the issues said it is controversial, and although delegates could vote to adopt it, the odds seems to be against it.

It’s too bad if the medical profession votes to remain under the big green thumb of Big Pharma.

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If doctors, labs, clinics, hospitals and medical colleges didn’t subscribe to the FDA-Big Pharma-Big Business view of what constitutes health care, many of our problems would vanish and we’d all be a lot safer — and healthier.

For the medical profession to recapture its original moral high ground of service-based ethics, it’s going to have to turn away from the Big Pharma-Big Business medical care paradigm that has developed over the last 30 or 40 years.

Two recent books, each by an experienced physician, take a fairly merciless look at the medical profession’s descent to a medical industry — with less than ideal results for its patients.

Both books are illuminating and should have wide appeal for patients and doctors, but the authors are asking a lot from both groups, each mired in nearly half a century of cultural habit and decayed expectations.

From the editorial reviews:

The Corrosion of Medicine: Can the Profession Reclaim Its Moral Legacy?
John Geyman, MD, traces the last 40 years of change in US health care, which has engulfed the profession in a marketplace now controlled by corporate and business interests. The profession’s long history of service-based ethics and its social contract have been called into question as the business “ethic” of bottom-line profits has spread throughout the system. The deregulated health care marketplace, now one-sixth of the nation’s economy, has had damaging impacts on health of the public as well as the profession itself.

Worried Sick: A Prescription for Health in an Overtreated America
Nortin M. Hadler, MD, argues that an even more important issue than access to health care is being overlooked. Although necessary health care should be available to all who need it, the current health-care debate assumes that everyone requires massive amounts of expensive care to stay healthy. Hadler urges that before we commit to paying for whatever pharmaceutical companies and the medical establishment tell us we need, American consumers need to adopt an attitude of skepticism and arm themselves with enough information to make some of their own decisions about what care is truly necessary.

In other words, individual physicians, the institutions that train them, and even patients themselves, could actually do something about the horrendous dangers and expense of health care in this country.

But will they?

Patients are already in revolt in their millions across the country. Through vigilance and speaking out — and more books like these from insiders — health care consumers are trying to overcome the pressures from Big Pharma and its minions at the FDA from regulating alternative health care into non-existence.

However, considering how tough it is to keep up payments on two or three Mercedes, a boat, a vacation home, membership in an exclusive golf club, and skyrocketing malpractice insurance, it’s not likely that some doctors will pay much attention. We can only hope that the doctors who really want the best for their patients will.

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After Congressional criticism for long delays, we are finally seeing some disciplinary actions against doctors involved in drug testing misconduct. 

Since January of this year, the FDA has banned seven physicians from conducting further clinical trials of drugs and medical devices, and that’s nearly three times the number sanctioned in the past three years.

The FDA can disqualify researchers who are found to be involved in misconduct, including falsifying results, during clinical drug and device studies.

That’s good news, because it has sometimes been years before actions are taken — long after investigations have proven misconduct, years during which the miscreants remain eligible to continue conducting studies for submission to the FDA.

Texas Representative Joe Barton, an outspoken critic of the delays, told Bloomberg News last week, “Doing something is a good sign, because delays have allowed people that do things that they shouldn’t be doing to continue.”

This is basically letting a convicted felon have a few years off after the trial to continue his or her career of crime before the state gets around to the bother of carrying out the sentence.

An FDA spokesman told Bloomberg that the rise in disqualification is a result of “newly established timelines for disqualifications”. But let’s face it — the increase is due to plenty of complaints from lawmakers about the lengthy delays that resulted in a damning report from a congressional committee. In February, the House Energy & Commerce Committee issued a report titled, “FDA’S Faulty Safeguards Against Corruption: Concerns Over Debarment Use And Authority.”

According to Joe Silverman in his Pharmalot blog, the report cites “a laundry list of FDA sins of omissions and commissions that raise numerous questions about the agency’s willingness to pursue corruption.”

The report shows that at least some lawmakers are concerned with at least some of the skullduggery and collusion between FDA puppets and their puppet master and Big Pharma, the FDA’s principle source of approvals funding. Too bad it’s only the researchers that are getting their wrists slapped. In every case, you can be sure, the researchers were stooges bending to the wishes — and the money — of Big Pharma.

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Former New York Times pharma reporter Melody Peterson has some definite ideas as to how the government, and the industry itself, could help bring about needed change.

In a recent blog I discussed Melody Peterson’s new book, “Our Daily Meds: How The Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines And Hooked The Nation On Prescription Drugs”. Ms. Peterson tells it like it is about Big Pharma’s descent into marketing hell at the expense of patient safety — with the help of a too-compliant FDA.

I was so pleased to find that Howard Brody had summarized Ms. Peterson’s recommendations in his blog Hooked that I decided to reproduce them here:

• Redesign the standard death certificate to make it easier to record prescription drug use as a contributing cause of death. Do many more autopsies to be sure we know what really has caused deaths.

• Outlaw physicians taking any money from the pharmaceutical industry. (If we can outlaw DJs taking money from record companies, says Petersen, why not?)

• Create an NIH-type agency to oversee pharmaceutical research and assure scientific integrity of results.

• Assure that patients receive the full information about drugs, in readily understandable form, before they are prescribed. (Petersen is sure that if patients knew how poorly many heavily advertised drugs really work, they’d refuse many of them.)

• Repeal FDA drug company user fees and generally stiffen the agency’s spine to regulate the industry.

• Stop covert drug marketing through celebrity endorsements, ads masquerading as news on local TV, health fairs and screening secretly funded by industry, and industry largesse to non-profit patient advocacy groups without disclosure.

• Do more testing of drivers who cause accidents for prescription drugs and require clear warning symbols on labels of drugs where driving is warned against. Punish docs who fail to warn their patients that they should not drive when taking a drug.

• Throw executives in jail if the company commits fraud–forget the “big” fines that companies now regard as a simple business expense.

• Focus more effort on prevention and less on taking pills after you get sick.

Now that is a comprehensive list of achievable goals that government and the FDA, medical agencies and physicians everywhere, the media, Big Pharma and the public should be chanting like a mantra. Thanks again to Dr. Brody and Hooked for the very neat summary.

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With 20,000 or more troops on prescription antidepressants and sleeping pills, the army’s military doctors are falling into the same destructive pattern as their civilian psych-pill-pushing counterparts, and troop suicides are skyrocketing.

According to Time magazine this week, 29 percent of American soldiers in Iraq and Afghanistan are on antidepressants and/or sleeping pills “to help them cope.” And the number reported taking drugs is probably underestimated, the article states.

“About 20,000 troops in Afghanistan and Iraq were on such medications last fall,” Time reports. “The Army estimates that authorized drug use splits roughly fifty-fifty between troops taking antidepressants — largely the class of drugs that includes Prozac and Zoloft — and those taking prescription sleeping pills like Ambien.”

The army, already struggling to maintain troop deployment numbers as well as morale, is drugging troops to keep soldiers with combat experience on the front lines. Joyce Raezer of the private National Military Family Association, says she recalls a military doctor saying, “Boy, it’s really nice to have these drugs so we can keep people deployed.”

Even professionals have their doubts. “Are we trying to bandage up what is essentially an insufficient fighting force?” asks Dr. Frank Ochberg, a veteran psychiatrist and founding board member of the International Society for Traumatic Stress Studies.

Another very real issue, and one that may be even more relevant in the long run, is the known increased risk of suicide among antidepressant users. Black box warnings added to the drug labeling in recent years warn of increased suicide risks in children, adolescents, and young adults ages 18 to 24 — the very age group at the heart of the Army.

The Time article asks if there is a link between the increased use of the drugs in Iraq and Afghanistan and a rising troop suicide rate there. Army suicides in Afghanistan and Iraq have reached 164 through 2007, with the annual rate now double the service’s 2001 rate. At least 115 soldiers killed themselves last year, including 36 in Iraq and Afghanistan, the Army says — the highest suicide rate since it started keeping records in 1980.

Nearly 40% of Army suicide victims in 2006 and 2007 took psychotropic drugs, overwhelmingly selective serotonin reuptake inhibitors (SSRIs) like Prozac and Zoloft. And outside experts do perceive a link between army suicides and prescription drug use. Dr. Joseph Glenmullen, who teaches psychiatry at Harvard Medical School, says, “The high percentage of U.S. soldiers attempting suicide after taking SSRIs should raise serious concerns.”

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Keep America drugged, and to hell with patient health, patient privacy, and state and federal direct-to-consumer marketing restrictions — Big Pharma is all about the buck.

Just when Californian’s thought their medical information was safely private, Big Pharma is taking an innovative whack at the golden goose — patients already on prescription medications.

Through a state senator apparently in its pocket, Adheris Inc., a subsidiary of Big Pharma drug marketing company inVentive Health Inc., has introduced legislation that end-runs patient privacy to sell more drugs.

Although California has one of the strongest medical privacy provisions in the country, the proposed legislation neatly sidesteps it to allow pharmacies in California to sell confidential patient prescription information to “third-party marketing firms” who, of course, all work for Big Pharma.

Supporters say the intent is to “remind patients to take their medicine and order refills.”
But no mechanism protects patients from receiving promotional material about other drugs or new drugs, and it’s entirely independent of patients’ doctors and pharmacies.

Naturally, consumer privacy advocates were outraged, and helped an earlier version of the bill get defeated a week ago. But the vote was so close — 17 to 17, and only 21 is needed for a pass — that its backers are trying again.

Encouraged by the closeness of the vote and perhaps by the idiocy of state senators in general rather than just those who voted in favor — and who knows what other incentives are flowing from Big Pharma towards this bill — Senator Ron Calderon, the bill’s alleged author, has amended it to — get this — allow patients to “opt-out” from the so-called “reminder plan” when they pick up their prescriptions.

Oh please. Can you see dear old Granny Jones, immigrants still learning English, or almost anyone else for that matter, refusing to receive reminders now and then to take their medicine? They can’t possibly understand what they’re opting into, or out of — and I certainly don’t expect pharmacy clerks to explain how it’s all a slimy marketing ploy. So when they’re asked BY THE PHARMACY if they’d like reminders, well of course, many will say: Sure, why not?

And then the profusion of slick, persuasive and nasty direct mail from Big Pharma will start avalanching into letter boxes, promoting new drugs, other drugs, our drugs over the other guy’s drugs, this drug, that drug — probably even drugs for conditions people don’t even have.

In his pharma-watch blog, Howard Brody sweetly and sarcastically sums it all up:

“The benign drug industry can send benign reminder notices to folks and benignly improve their health.” Yeah, Howard, that’s it exactly!

The amended bill will get a new vote next week. We hope enough elected reps keep their wits about them and recognize that this latest scam from Big Pharma is just pharma business as usual — keep America drugged, and to hell with patient health, patient privacy, and state and federal direct-to-consumer marketing restrictions. It’s just about the buck.

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With reports rolling in about mental and physical side effects, Pfizer’s prescription anti-smoking drug Chantix is only the latest problem facing the company, and indicative of deeper problems with our country’s drug testing and approvals system.
Pfizer Inc. has problems, and far too many of them seem to involve law suits. As one wag on the Wall Street Journal’s Health Blog commented, “No wonder they appointed a lawyer as a new CEO in 2006.”

The firm’s smoking-cessation drug Chantix is undergoing major re-evaluation following a storm of reports about adverse side effects, both physical and behavioral. The latest blow came this week when the Federal Aviation Administration (FAA) banned airline pilots and air traffic controllers from using the drug due to concerns about “adverse neuropsychiatric effects which could be detrimental to public safety.” The FAA’s action is expected to spread to all public transportation operators, such as railroad  engineers, subway motormen, long-distance haulers, and even taxi drivers.

More than five million people have taken Chantix in the US, according to Pfizer. But the Chantix problems started a couple of years ago with reports of behavioral, or “psychiatric”, side effects. The FDA reported last November about numerous patients using Chantix experiencing suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. Then in February it issued an Alert, saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”

This week we are reading about a much wider spectrum of problems. The Institute for Safe Medication Practices analyzed adverse event reports published by the FDA for research use, and has reported that Chantix-related injuries include serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide.

Last Sunday, the LA Times reported that over two dozen traffic accidents have been linked to Chantix and reported to the FDA. Warnings were previously issued by Pfizer regarding the risks of Chantix while driving, but these warnings are largely ignored by doctors and patients, the story said.

As for Pfizer’s recent problems, development of its cholesterol-lowering drug Torcetrapib was halted in 2006 when phase III studies showed “excessive mortality” in the treatment group — in real language, real people died unnecessarily. And in 2004, Pfizer acknowledged the cardiovascular risks of painkiller Bextra, and the American Heart Association received a report showing patients recovering from heart surgery using Bextra were more than twice as likely to suffer a stroke or heart attack than those taking placebos — in other words, more people died unnecessarily.

But it wasn’t until April 2005 that Pfizer finally had to withdraw the pain-killer from the U.S. market after the FDA formally cited the increased risks of heart attack and stroke, and a serious, sometimes fatal, skin reaction.

We are reminded of the highly-publicized case of musician Carter Albrecht who was shot to death by his neighbor who was reportedly on Chantix. In the wake of this story, the FDA recommended that health care professionals and patients watch for behavioral and mood changes.

The problems with Chantix and the rest of Big Pharma’s problem drugs loudly and strongly indicate what’s wrong with America’s drug testing and approvals system. While we acknowledge that almost any drug will have side effects of some kind, and that side effects can be wildly different from person to person, it is perfectly clear that too many drugs are approved by the FDA with insufficiently comprehensive clinical trials. Warnings coming way too long after deaths and injuries. As usual, it’s just too little, too late — for Carter Albrecht and everyone else.

Millions of American patients have become the real lab rats for pharmaceutical testing. But this takes added weight considering the revelations of Big Pharma’s altering and withholding known adverse reactions — deceiving not just the FDA, but also our physicians and us, the public — all for monetary gain. This raises the problem from a technically faulty testing system to a criminal activity — with malice aforethought.

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