Drug Company Corruption, Pfizer Edition

The level of pharmaceutical company corruption is breathtaking.

A research director for Pfizer was positively buoyant after reading that an important medical conference had just featured a study claiming that the new arthritis drug Celebrex was safer on the stomach than more established drugs.

“They swallowed our story, hook, line and sinker,” he wrote in an e-mail to a colleague.

The truth was that Celebrex was no better at protecting the stomach from serious complications than other drugs. It appeared that way only because Pfizer and its partner, Pharmacia, presented the results from the first six months of a yearlong study rather than the whole thing.

The companies had a lot riding on the outcome of the study, given that Celebrex’s effect on the stomach was its principal selling point. Earlier studies had shown it was no better at relieving pain than common drugs — like ibuprofen — already on the market.

 

Long-Term Opioid Use Questioned at FDA Hearing

Recently, I’ve been reading and thinking a great deal about the use of prescription drugs for pain. Opioids are clearly the flashpoint for current debate.

From today’s MedPage:

Opioids used to be prescribed primarily for cancer pain and short-term relief immediately after surgery or an accident. But that changed in 1996, when the American Academy of Pain Medicine and the American Pain Society — organizations that get substantial funding from drug companies — issued a joint statement endorsing the use of opioids to treat chronic pain and claiming the risk of addiction was low.

Since then, drugs like OxyContin and Vicodin increasingly have been used to treat a wide array of chronic pain syndromes including low back pain and fibromyalgia, despite a lack of good scientific evidence to prove that their benefits outweigh potential harm when used long term. Opioids are also increasingly being prescribed to the elderly, often for chronic pain.

The Obama administration has called the current prescription drug abuse epidemic a “public health crisis” worse than the crack and heroin epidemics of past decades. In 2007, there were 28,000 deaths from prescription drug overdoses — five times the number in 1990. Those deaths were driven largely by the abuse of prescription painkillers. Painkiller abuse now matches abuse of illegal drugs.

“[Opioids’] increasing use has resulted in a clearly unacceptable increase in addiction, overdose, and death,” Douglas Throckmorton, MD, deputy director for regulatory programs at FDA’s Center for Drug Evaluation and Research, said at the meeting.

But the meeting didn’t focus on safety concerns with opioids; rather, it focused on efficacy and effectiveness, and attendees discussed the existing evidence to support giving pain patients opioids long term.

Supplements, Especially Those for Bodybuilding and Weight Loss, Linked to Liver Disease

Today’s MedPage includes a report on a study linking supplement use to liver damage.

A few comments…

I find it revealing that the study’s authors report a long list of drug company conflicts of interest and that “supplements” are to a large extent lumped into one overall category, which has the effect of creating a generalized anti-supplement narrative.

That said, the fact that bodybuilding and weight loss supplements seem to be the main culprits appears to be an important finding.

It would be most helpful to find out exactly which supplements we’re talking about. But all we’ve got at this point is an abstract from a poster presentation at a digestive diseases conference.

I will be interested to see if this results in a flurry of anti-supplement stories in major media in the coming days, despite the lack of publicly available data to analyze the findings and respond to the clearly anti-supplement narrative.

If certain supplements are dangerous, that’s definitely worth publicizing. But to tar all supplements with the same brush is disingenuous at best.

Cancer v. the Constitution

A human tragedy, which could become much less common or much more common depending on what the Supreme Court decides.

She hadn’t gone to the doctor because she had no health insurance. The only kind of work she could get in a struggling rural community was without benefits. Her coat and shoes beside the gurney were worn and her purse from another decade. She could never afford to buy it on her own. She didn’t qualify for Medicaid, the local doctor only took insurance, and there was no Planned Parenthood or County Clinic nearby.

So nothing was done about the bleeding until she passed out at work and someone called an ambulance. She required a couple of units of blood at the local hospital before they sent her by ambulance to our emergency department.

I looked at the fungating mass on her cervix. Later the Intern wondered why she hadn’t picked up on the smell. Probably a combination of it being so gradual and denial. It’s amazing what people learn to tolerate when their options are limited.

“I’m very sorry to tell you this looks like a cancer of the cervix,” I said

She looked surprised. “Oh.” She paused in silence as she adjusted to the news. And then quietly she added, “But the doctor back home said you could fix me up. He said you can offer free care because you have the university.”

But we didn’t have free care at the university hospital.

h/t Meteor Blades

Why Adjust the Dosage on a Useless Drug?

Merrill Goozner is among our nation’s best health policy reporters. His concern about this FDA decision is one that makes a great deal of sense.

Professors Lisa Schwartz and Steven Woloshin of the Center for Medicine and the Media at The Dartmouth Institute for Health Policy and Clinical Practice are raising alarms about a recent Food and Drug Administration decision to approve a new dosage for the  best-selling Alzheimer’s drug Aricept (donepezil). The decision “breached the FDA’s own regulatory standard” and has led to “incomplete and distorted messages” about the drug, they warned in the latest British Medical Journal.

Aricept has become a $2 billion-a-year blockbuster in large part because people caring for elderly patients with dementia are desperate for something, anything to slow their loved ones’ inexorable decline. The original dose for the drug, which was approved in 1996, provided a short-term improvement in memory that faded to insignificance within six months. With its patent due to expire, the companies behind the drug — Eisai and Pfizer — went to the FDA with a clinical trial in 1,400 patients claiming a higher dosage showed better results. The FDA agreed, which gave the companies another three years of marketing exclusivity based on a use patent for that new, higher dose.

Here’s the medical problem with that higher dosage, according to Schwartz and Woloshin. While the clinical trial showed that patients did slightly better in cognition (like recognizing numbers), the drug had no impact whatsoever on their actual functioning in day-to-day life, at least none that their caregivers could notice. Yet the major side effects of the drug — nausea and vomiting — increased significantly. The article claimed that the FDA had said specifically to the trial sponsors that the higher dose had to have an impact that caregivers could notice to win approval. Schwartz and Woloshin charged the FDA with violating its own standards.

Supreme Court Unanimously Rules Against Patenting “Laws of Nature”

This is a most promising development. The biotech companies’ willy-nilly rush to patent everything in sight had to end somewhere. It’s important not to generalize too broadly from this ruling, but it does seem to be a line in the sand that even this corporate-friendly Court felt compelled to draw. Good for them!

The unanimous Supreme Court decision said, “Laws of nature, natural phenomena and abstract ideas are not patentable” under provisions of the US Patent Act.

To be covered by a patent, “an application of a law of nature… must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law,” said the decision written by Justice Stephen Breyer.

“The claims are consequently invalid,” said the court’s decision, which reversed an earlier ruling of the US Court of Appeals for the Federal Circuit.

The patents covered a method developed by Prometheus Laboratory for adjusting dosages of thiopurine treatment for patients with immune system diseases, such as Crohn’s disease, a chronic intestinal inflammation.

The unanimous Supreme Court decision said, “Laws of nature, natural phenomena and abstract ideas are not patentable” under provisions of the US Patent Act.

To be covered by a patent, “an application of a law of nature… must do more than simply state the law of nature while adding the words ‘apply it.’ It must limit its reach to a particular, inventive application of the law,” said the decision written by Justice Stephen Breyer.

“The claims are consequently invalid,” said the court’s decision, which reversed an earlier ruling of the US Court of Appeals for the Federal Circuit.

The patents covered a method developed by Prometheus Laboratory for adjusting dosages of thiopurine treatment for patients with immune system diseases, such as Crohn’s disease, a chronic intestinal inflammation.

FDA Panel Urges Studies on Pain Drugs Known to Have Severe Side Effects

Somehow I suspect this will not end well.

Particularly because the conditions listed as potential indications for prescription of these clearly dangerous drugs are so common — chronic low back pain, osteoarthritis, and diabetic peripheral neuropathy — this has all the hallmarks of a trainwreck in slow motion.

Few if any people would want to rule out the use of even dangerous painkillers for people with, say, intractable cancer pain. But to jump from that potentially appropriate use (as the pharmaceutical companies always do) to using them from low back pain or arthritis, is breathtakingly irresponsible.

An FDA advisory committee has voted 21-0 that the investigational anti-nerve growth factor (anti-NGF) drug class should continue to be developed for pain treatment, despite the drug class’s link to joint-related adverse events.

There are no anti-NGF drugs currently approved, but three companies are deep into their development programs, testing the safety and efficacy of the drug class to treat a variety of pain, including pain associated with osteoarthritis, chronic lower back pain, diabetic peripheral neuropathy, post-herpetic neuralgia, chronic pancreatitis, endometriosis, interstitial cystitis, vertebral fracture, thermal injury, and cancer.

For Monday’s meeting of the Arthritis Advisory Committee, FDA researchers reviewed data from the three drug companies and concurred with earlier findings that anti-NGF drugs do appear to cause rapid joint destruction. In patients who already had osteoarthritis, the joint deterioration was more severe than if their disease had progressed naturally, and, in some cases, patients who did not have osteoarthritis developed rapidly progressing joint deterioration during the trial.

Lower doses and less frequent administration of anti-NGF agents as well as placebo were both associated with naturally progressing osteoarthritis, while higher doses of anti-NGF drugs and use of an NSAID was linked to rapidly-progressing osteoarthritis as well as osteonecrosis.

An FDA reviewer and an outside academic reviewer performed separate analyses on 355 cases where patients receiving anti-NGF drugs underwent joint replacement surgery. Of those cases, 21% were determined to be rapidly-progressing osteoarthritis, and 7% were determined to be osteonecrosis.

For those not familiar with the terms, osteonecrosis is death of bone tissue and osteoarthritis is joint degeneration.

The ironic fact that the nonsteroidal anti-inflammatory drugs (ibuprofen, Advil, Motrin, etc.) routinely used for arthritis yield short-term pain relief but also cause long-term joint deterioration due to thinning of cartilage, is little known to the public. The FDA panel’s report on these anti-nerve growth factor drugs indicates that these, too, are known in advance to involve similar (and perhaps far more severe) trade-offs.

Not exactly what the doctor should order.

Blunt-Rubio “Contraception” Amendment: A Stealth Attack on Essential Health Services?

Press coverage this week on the Blunt-Rubio amendment to a Senate highway spending bill focused to a large extent on its sponsors’ stated goal of allowing employers to deny contraceptive coverage in health plans offered to their employees, based on religious or moral objections. Republicans sought to frame the issue as freedom of religion while for Democrats, it was primarily an attack on contraception and, more broadly, on women’s rights.

It is important to realize that impact of Blunt-Rubio, were it to be enacted into law, extends far beyond contraceptives, sex, and religion, taking aim squarely (if quietly) at the entire idea of requiring insurance plans to cover what are deemed “essential services.” It is no exaggeration to say that this proposal has the potential to thoroughly undermine the long-established process of requiring insurers to cover a defined set of health services.

This amendment, which only failed by a 51-48 vote, would allow all employers to determine whether or not to deny coverage for contraceptive services, regardless of whether the Institute of Medicine, Department of Health and Human Services, or state insurance regulators judged these to provide substantial health benefits. But more signifcantly, what it would also do is to allow any employer to eliminate coverage for any health care service, based on the religious or moral beliefs of the CEO or other decision makers.

How do we define moral beliefs? Our morals may be based on religious teachings (Catholic, Protestant, Jewish, Hindu, Buddhist, Muslim, Scientologist, Wiccan, etc.). Or, they may be based on anything else we choose to believe. Morals are quite personal and American society is exceptionally diverse in the range of moral beliefs professed by its citizens. Your moral beliefs may be based on deep philosophical inquiry and meditation, or they may be based on the last thing you heard on your favorite talk radio station.

If you are a CEO who strongly believes that vaccination is immoral because it violates the sanctity of the body as a temple, or any other reason), should you be able to eliminate that coverage from your employees’ list of covered services? How about a CEO who has joined the Church of Scientology and decides as a result to eliminate psychiatric benefits from his employees’ coverage? Should a corporate leader who considers sex outside of marriage to be immoral be permitted to eliminate not only coverage for abortion or contraception but also prenatal care for those who transgress his moral code?

Where does this stop? Blunt-Rubio is silent on that question, with its advocates preferring to limit the discussion to contraception. Did they not think it through? Or is this a stealth attack on government’s ability to define essential services and require insurance policies to cover them?

The implications are truly breathtaking in their comprehensiveness. Any employer can deny any health service for any reason, as long as he or she states that their objection is “moral.”  This is philosophically consistent with the conservative philosophy of governance that judges democratically elected officials to be the worst imaginable source to depend on for health care policy, choosing instead to vest that power in the hands of the private sector, specifically corporate CEOs or those to whom they delegate their power.

Is that the kind of health policy you favor?