Tuesday, January 04, 2005

News Flash: All Drugs have Risks!

On the heels of recent findings regarding Vioxx, Celebrex, and Alleve, comes a new warning regarding ibuprofen.

According to a study from Baylor College of Medicine, in Clinical Gastroenterology and Hepatology entitled Visible small-intestinal mucosal injury in chronic NSAID users, ibuprofen is unsafe for long-term use. It found that
Some 71% of the NSAID patients showed signs of small bowel injury, compared to just 10% of the controls.
According to researcher Dr. David Graham,
"We saw some ulcers and we saw lots of erosions. Anybody who takes aspirin or (other) NSAIDS for a year has a 1% to 4% risk of serious gastrointestinal complications."
Unfortunately, that leaves us with just tylenol and various narcotics as pain relievers.

As Thomas Sowell discusses, all decisions have trade-offs between risks and benefits. No choices come completely free of risk.
Where do people not recognize trade-offs? Where they are making decisions for other people. That's where they make unrealistic demands, including demands for "safety." Maybe Vioxx or Celebrex is too dangerous, all things considered. Maybe not. The problem is that all things are not considered.
He makes the excellent point that "nothing is categorically safe", and that all of life involves weighing weighing risks, benefits and alternatives. If we really considered absolute safety as our primary objective in life, we'd never get into an automobile. Ever. We would give up chemotherapy, surgery and antibiotics as well, for they have even larger risks than do painkillers.

The recent march against NSAIDs and COX-2 inhibitors is especially foolish, inasmuch as we have frighteningly few pain medicine alternatives.

Next news flash: tylenol, aspirin and narcotics are bad for you!!


Egan Allen said...

It might be a flash for many in the general public given pharma's snake-oil advertising techniques and the decreasing [time with doctor]:[medical complexity] ratio.

With increasingly brief appointments with doctors patients are left with lists four miles long given to them by the pharmacist listing potential side effect profiles (docs don't have time to list even a few). Sometimes too much information (on these lists) is like none at all.

The net result is that prescriptions are written with poor "informed consent" practices being followed. Academic docs who have residents to slog through some of this for them is one thing (I have been in this world); it just isn't the case out in the trenches (I am currently in this world). Some of my internal medicine colleagues see 30+ patients per day. Where is the time to reliably explain risks and benefits with such a volume?

The witch-burning reaction to pharma right now is therefore no surprise--it is evidence that "All drugs have risks" is REALLY A NEWS FLASH!


KCFleming said...

Regarding your comment:
"With increasingly brief appointments with doctors patients are left with lists four miles long given to them by the pharmacist listing potential side effect profiles (docs don't have time to list even a few). Sometimes too much information (on these lists) is like none at all."So how is this big pharma's fault? How long an appointment would be required to complete an exhaustive of potential side effects anyway? Who would pay a doctor for this? What responsibility do patients have for what they put in their mouths?

I agree it would be nice to have a long conversation about all the potential side effects of taking a baby aspirin every day to prevent heart attacks. Covering all of the risks, ratios, and answering questions would take 45 minutes to an hour. And if I did that for every drug, device and planned intervention, I would see maybe two or three patients a day. And I would starve to death.

Roy M. Poses MD said...

But the reason you can't get paid is that those who control reimbursement (a mixture of Medicare and private insurers and HMO's) are wedded to five complex and arbitrary categories of office visits. These categories do not allow for greater reimbursement for a longer visit during which benefits and harms of therapy are discussed.
But where is it written in stone that the reimbursement system cannot pay physicians for spending extra time with patients to explain benefits and harms in more detail? The current system seems to persist partially because patients have no input into it.
After all, due to tax laws, and history (that is, or wage controls during World War II), employers take money they could have paid to employees as salary, and instead purchase health insurance with that money, deducting what they pay from their corporate income tax. Because they do so, the employers seem to have assumed the right, as "payers," to make decisions about the sorts of health insurance that their employees can have.
Imagine changing the tax laws so that employers could not deduct health insurance benefits, but employees could deduct what they pay for health insurance. Then employers might add what they used to pay for health insurance to salaries, and their employees would take this extra salary and pay for their own health insurance. Then it would be up to the insurers to compete for individual policies, rather than ply their wares with a few benefits directors of large corporations. (A law mandating community rating might be necessary here.)
Then some individuals might choose an insurance plan that would pay a doctor for the amount of time spent with the patient, and allow a larger payment if the patient wishes to spend more time discussing benefits and harms.

InformaticsMD said...

All drugs have risks, but, as pointed out at http://www.thestreet.com/_yahoo/stocks/melissadavid/10201457.html

When activists were battling to accelerate the approval of AIDS drugs in the late 1980s, they surely never dreamed that a souped-up pain pill like Vioxx would ride on their coattails ... While some treatments clearly merit special handling, critics say, the push to bring new products to market has compromised the integrity of the agency's drug-approval apparatus.

... The drug industry drove a Mack truck through the exception created for life-threatening illnesses," Weinstein [Michael Weinstein, president of the AIDS Healthcare Foundation] continues. "Basically, everything became 'fast-track.' "

... Weinstein calls Vioxx a "me-too drug for arthritis pain" that should never have merited a priority FDA review. He claims that Merck "hijacked" the fast-track approval process, which allows drugs to hit the market after just six months of study by the government, and unnecessarily placed the public at risk as a result.

So, it's not that drugs have risks that is the major issue. It's the unbridled drug-pushing that seems to be the problem.

KCFleming said...

Roy stated: "the employers seem to have assumed the right, as "payers," to make decisions about the sorts of health insurance that their employees can have".

I fully agree that people should have the right and ability to spend as much time with the doctor as they want. I also agree that the driver of short visits preventing lengthy discussions is the mechanism we have for funding (although not just employers but Medicare as well is so designed).

However, I suspect in the patient-centered market (i.e. free market), I suspect very few people would be willing to pay for a lengthy sit-down discussion of a "litany of the saints" review of all or even most side effects. When many patients use 5 or more drugs, need a procedure and have other concerns, I suspect few will be desirous of such discussions when it's on their dime. Color me skeptical, but I think few people will be able to afford long discussions, and short visits will be the norm.

Moreover, the primary reason for the lengthy review of the side effect profile is liability, isn't it? Sure, sure, we all want informed consent, but I stand by my estimate. If you really reviewed every patients drug profile this way, you'd be unable to see but a few patients each day.

Instead, I'd suggest we permit education of patients to occur at some other level, not involving the MD in person. Unless of course you mean to pay MDs minimum wage. That would work, at least, in lengthening the visits.

KCFleming said...

Re: "So, it's not that drugs have risks that is the major issue. It's the unbridled drug-pushing that seems to be the problem."We'll have to remain in disagreement on this one. Anger at Pharma seems a poor reason to abandon perspective however, and I think we have lost perspective. The cardiac risk of Vioxx needed to be considered against its benefits. Whether or not one is fond of Pharma advertising or profits is irrelevant.

Roy M. Poses MD said...

But pharmaceutical company direct to consumer advertising (of both Vioxx and Celebrex), hardly encouraged the cool, rational balancing of risks and benefits. Clearly, the advertising did not suggest that Cox-2 inhibitors were second-line drugs only to be used for patients with significant chronic pain who had high risks of gastro-intestinal bleeding, or had failed multiple standard NSAIDS. They suggested that the drugs were first line treatments of practically any painful condition.
Furthermore, the advertisements had the effect of inspiring patients to pressure their physicians to prescribe the drugs. Such pressure is not conducive to cool, calm, collected discussions of risks and benefits (whether or not physicians are paid fairly to take the time for such discussions.)
Of course, one also wonders what managed care was doing about the pharmaceutical companies' direct to consumer advertising strategy. Rather than designing counter-advertisements for the general public, or educating patients about the general principle of balancing benefits and harms, managed care chose to put more pressure on the physicians, but in the opposite direction, against prescribing expensive drugs. This was yet another example of physicians and patients caught in the cross-fire between big health care organizations.