by Michael Kirsch, MD
Demonizing the pharmaceutical industry has become a parlor game for many who enjoy the challenge of shooting at an oversized target. Scapegoating Big Pharma? Now, that takes guts.
Never mind the gazillions they spend on research and development to create tomorrow’s treatments for cancer, arthritis, depression, infectious diseases, heart attacks and strokes. I know that drug industry executives are not all eagle scouts whose mission is solely to save humanity. But, they are not an evil enemy that we need to contain like the “swine flu” pandemic. Sure, they make a profit, and they deserve to. Drugs cost multiple millions of dollars to develop, and most of them never make it to market. Those that do, after years of testing and F.D.A. review, can be summarily shut down when unexpected serious adverse reactions are suspected. In these cases, there may be no actual proof that the medicines were responsible for the ‘side effect’.
I’m not suggesting that we demand airtight proof before issuing drug warnings, only that we beware of what happens if drug company profits can be decimated with the stroke of a pen. Playing rough with the drug companies may appeal to our populist sensibilities, but it can go too far and stifle innovation.
Drug companies need the promise of large profits if they are to take the risks inherent in developing new and novel medicines for all of us. What other business would invest in a new product or technology without the potential for substantial financial gain? Before we advocate price controls for medicines or shortening intervals of patent protection, consider the side effects of this clumsy approach. If we hit Big Pharma too hard, then they will play it safe and churn out lots of drugs that we don’t really need.
Which would you rather they invest in? Another drug for heartburn that is no better than all the others on the shelf, or a vaccine to prevent cancer?
If they succeed in the latter endeavor, I hope they earn hundreds of millions of dollars. This will still be less than the number of lives they will save.
Michael Kirsch is a gastroenterologist who blogs at MD Whistleblower.
Submit a guest post and be heard.
Related posts:
- Pharma TV
- Big Pharma realizes their folly on direct to consumer advertising
- Bill Gates on Big Pharma
- Is fibromyalgia real, and if so, are drug companies profiting from the uncertainty of the disease?
- Secrets of the pharmaceutical industry
- "Pay to delay": How Big Pharma is paying off generic drug companies
- Why don’t drug companies use Twitter?
{ 2 trackbacks }
{ 16 comments }
I agree. I’m an RA patient with Enbrel (Etanercept) to thank for my ability to work, exercise, hold a pencil, cook a meal, and just about everything else I do in my day to day life.
Yes, I’d rather it didn’t cost $22,000 (Canadian) a year, and I’m not deluding myself into thinking the people who market it are entirely altruistic. But competition and profit are an incentive we’ve seen the benefits of.
That said, there do need to be fewer barriers to patient access. Whether that’s through government programming, earlier access to generic versions of drugs, or something else nobody has thought of yet, it needs to happen. (I know, of course, that the systems are different in the U.S. and Canada, but I think getting people the drugs they need can present a problem in both countries).
Companies are not evil. They are more like machines. Constructed by people, programed to make profit, and built to last or morph. A company, especially a company with shareholders, does not have feelings or conscience. They might have codes of ethics, but in the end they only do this for the end result – profit. And that is not bad – it’s just the way it is. At their best they can be an asset to society. At their worst, companies can be like terminators.
I think Doctors need to take some resonsiblility here, too freely are drugs handed out. What happened to the old fashion “exam a person” instead of handing out scripts..
Villain may be a strong word, but stating they aren’t “villains” doesn’t let them off the hook.
Drug companies (perhaps with excellent motives) bear much responsibility for the astronomical rise in cost of healthcare. While a lot of the new drugs are needed, a lot are “me too” drugs to “replace” generics that doctors and patients never asked for. Drug companies bank on the “newer is better” mentality of patients and doctors to get millions of patients on drugs that cost 10 times more than generics that work just as well.
Fixing healthcare is going to require a lot of work. Simply pointing out “we do good work” doesn’t exempt drug companies from having to change.
This is ridiculous. First of all, the drug to treat Gaucher;’s disease was discovered by the NIH, and then given freely to a drug company, so they gouge American taxpayers at 20000 dollars a shot. They reaped billions and the so called R & D costs were practically zero.
Secondly, when a company spends money to create a “me too” drug with little benefit or no new benefit to offer, how is this worth a generous profit?
Also, so much money is spent on advertising Viagra and Crestor in direct-to-consumer ads, that those costs are (inappropirately) passed on to the consumer (obviously). why are these ads even allowed to air? I’ve blogged about this before, but its all about (surprise) money.
As for “Undiagnosed”’s coment, I would just say that you don’t have any idea what you’re talking about, and congratulations on playing right into the hands of drugmakers and insurers who WANT you to blame doctors along with the companies, just to cloud the fact that they are the real culprits. Doctors have no sway with Congress or the President. Look at the hapless AMA. Meanwhile, all the doctors in America aren’t worth a hundredth of one insurer or drugmaker.
May be a little restraint in pricing the meds to high should be enough.
I think everyone agrees that direct to consumer advertising of pharm. drugs does not have a patients best interest in mind. that is not whats being debated.
It is highly unlikely that even with billions of dollars we will be able to create a vaccine against cancer, give our current lifestyle choices.
-Dr Main
The campaign against the drug companies stems from lawyers and insurance company. They are being demonized so that patients will be moved to generic medications.
As a patient, I am appalled at the passivity of the drug companies themselves. They should be counterattacking the enemies of clinical care. They are settling and encouraging further attacks. Aside from lawsuits and direct actions against these mortal enemies of clinical care, the Congress should enact a statute allowing the spread of evidence supporting off label uses. The FDA is an anti-free speech oppressor. Off label uses are the single biggest source of innovation and improvement in health care at no additional cost.
Patients may have to form direct action groups and counter-attack the enemies of clinical care. There is full moral and intellectual justification for attacks on people trying to kill them by depriving them of innovative treatments.
“gazillions the spend on research” Not so. To camouflage the amount they do spend they roll it into their marketing budget so you can’t tease it out accurately. Further of the 400 or so new drugs each year, about 6 are true improvements. If you check most of these remaining were not made by American companies. You can look up all this by reading Dr. Marcia Angell’s deep analysis of the pharmaceutical industry. They have done very well in papering over their abuse of patent laws and true sources of research(university and medical school labs).
“This economic model skews the budgets of
pharmaceutical companies, with only about 10% of
drug revenues actually going toward R&D, and less
than a fifth of that – just 2% of the total — going
toward truly innovative products. The rest of the
R&D funds are spent on existing products or “me
too” drugs that are not significantly better than
existing ones (Angell 2004, Love 2003). In fact,
only about 25% of new drug approvals are rated by
the Food and Drug Administration to have any
therapeutic benefit over existing treatments (NIHCM
2002).”
“Supremacy Claus” are you by any chance a drug rep?
I’ve just never heard anyone but a drug rep call generic medicines “enemies of clinical care.” Most generics are safe and affordable treatments for patients. Most evidence based off-label indications are in generic meds, because if there is any good evidence for another indication for a big money drug the drug company pays to apply for the indication.
Such disingenous cheerleading for pricy drugs over well-proven generics is exactly the reason I don’t talk to drug reps anymore. I appreciate the companies making “inovative treatments,” but lay off the baseless attacks on evidence-based older treatments. If your new product is so innovative you won’t need to rely on drama and sophistry to sell it.
Doctor D: Are you in any way an insurance company stooge? Personal remarks show frustration in the debate and are not useful.
I happen to be a patient and the relative of several patients.
As to evidence based medicine, it has its problems. One is a basic error. Most studies use parametric statistics (based on the bell shaped curve). These reliably predict the response fractions in the larger population, assuming the required criteria are obeyed. The most crucial is random selection of subjects. That is always disobeyed. The worst patients are always excluded to avoid being sued by the lawyers and left wing extremist advocacy groups.
The problem? Clinical care s a series of on-off, individual case experiments. That activity is described by the binomial distribution (like flips of a coin). You cannot apply a parametric finding to binomially distributed activity, the individually decided treatment of one patient.
So evidence based medicine is itself garbage science. It is promoted by HMO’s to force doctors into cheap care. The insurance goons know that from 11th grade statistics courses. They are just lying.
Any doctor sued for malpractice where guidelines are mentioned, should file a cross claim against the authors of the guidelines, all their employers and sponsors. These are enemies of clinical care and peddlers of garbage science. To deter.
Supremacy Claus,
Sorry for asking if you were a drug rep. It was a real question in my mind based on your comments, not a personal attack.
Am I right in understanding your argument is that since clinical trials won’t predict an individual’s response to a drug they are garbage? So a doctor should ditch what has worked effectively and safely for the larger percentage of test subjects and start fresh with each patient?
If I have to start fresh with each patient I could just start with the medicines in the PDR that start with “A” and work my way through alphabetically. I could try a chemotherapy drug for hypertension because previous trials on others cannot prove it wouldn’t be the perfect med for this individual’s blood pressure.
Is it not reasonable to start with the less expensive meds with proven efficacy and safety in others in a similar situation, before going to the $150/month med with the cool TV adds and the less proven record?
I don’t do this as a favor to insurance, and I am always willing to use more expensive meds if my patients fail the cheaper ones. Unlike the Pharm Companies and Insurance Companies, however, I take responsibility for bankrupting this country seriously. I do my patients a favor both financially and medically to start them on a more-proven $4 med before a less-proven med that will cause their premiums to rise.
Doctor D: That a drug is superior to placebo in a clinical trial is useful as a screening tool. And it will be superior at the population level if the assumptions of parametric statistical testing are obeyed. The most important is random selection. As the doctor excludes few from his practice, so few should be excluded from clincal trials.
Trying all meds for all conditions might get you the shocking result that antibiotics is a treatment for stomach ulcers. You know chemo makes people nauseous and thin. How about tiny doses for morbid obesity?Who knows until tried in the field? Some desperate doc facing a desperate patient will try that. If it works? Around the world in a month.
Sometimes a clinician will find a remedy as surprising as that. He doesn’t even need to publish. It will tried by others, within weeks around the world. If it works for others, it becomes standard of care informally. Four years later, an academic will get a grant to test it. Three years after that, it gets published. Towo years after that, articles will get gathered to update the guidelines. So evidence based medicine is also the medicine of nine years ago. Meanwhile, the clinician is doing almost nothing he was doing nine years ago.
Your approach to the individual patient is good. I go farther than you do. I propose putting many safe and effective medications over the counter. Make all guidelines in plain English. Allow patients to use them. For example, patients with hypertension can take lisinopril on their own.
Guidelines as advice, as reviews of the subject for docs and patients learning? Great. As mandatory orders to the doctor, enforced by regs or medmal verdicts? No way.
Trying antibiotics for ulcers (H. pylori, I presume) was not a random attempt in some family practitioner’s office. It was the result of work done in a basic science lab.
Supremacy Claus, how are you supposed to treat your hypertension if you haven’t been diagnosed? And how is a hypertensive supposed to know which anti hypertensive is correct? Diabetics get one kind, isolated systolic hypertension get another. And who’s going to monitor the potassium and creatinine once you are on lisinopril. Your very example shows how ill equipped non physicians are to treat even the most well known and pervasive diseases. I agree with Chris, your entire paradigm for medical discovery simplifies how much research and hard work actually lies behind the drugs we have now.
The fact is, private drug company research driving innovation has failed. Its time for the government to step up and dump a lot of money at the NIH to fund it, otherwise we won’t have any antibiotics soon.
I have an issue saying that private drug company research has failed to provide innovation – look at the great things happening in oncology pipelines at places like Genentech & Pfizer.
Do you really think the NIH is going to be more productive in creating better medications? Really?
Comments on this entry are closed.