US pharmaceuticals have an extraordinary level of safety

Glaxo-Smith-Kline agreed to pay $750 million to settle a case involving defective drugs. As far as I can tell, no definite harm from these drugs was documented.

That’s what I love about our health care system.  The level of safety we expect is extraordinarily high.  FDA rules on drugs demand an extraordinary level of safety expectation.

When people ask me what I think of “natural” treatments for their conditions, I tell them that I feel much safer with an actual medication, because our medications are extraordinarily well-defined and safe.  Reputable American pharmaceutical companies don’t take chances. The risk to them of making a mistake, as GSK did here, are enormous.

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It’s unfair to keep generics off the market

A generic manufacturer received tentative approval from the FDA to market at generic version of the cholesterol controlling drug Crestor — a multi-billion dollar product — that’s right, a multi-billion dollar product.  Crestor’s manufacturer will likely try to fight off generic competition for as long as possible.

Like so many other issues in medicine, a balance is needed to promote the development of new products while still allowing generics to bring down the cost of treatment. While people can argue about whether or not our current system is optimal, the system has worked rather well. We have so many great products that we didn’t have 20 years ago. As the new products go generic, the medical miracles become even more affordable.

There have been other stories in the news about brand name drug manufacturers paying generic companies to keep the generic off the market.  This is unfair.  Perhaps there should be a law against it.

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Physician/pharmaceutical company transparency is welcome

The pharmaceutical company Merck sent me a letter describing Merck’s upcoming efforts to implement greater transparency in their business.  This will include public disclosure of payments to physicians who speak on behalf of Merck.

This, and similar programs started by other pharmaceutical companies, is most welcome.  I think it is only fair that patients know if their doctor is taking money from drug companies.  This way, patients will get to see if their doctor is considered a cutting edge expert whose advice is sought by companies and by other physicians. It also will give patients a sense if they should be at all concerned about whether their doctor’s decisions are influenced by company relationships.

This hot topic is the subject of another Getting Better Health Care radio program, in which I interview Dr. Guy Chisolm, Director of the Innovation Management and Conflict of Interest Program at the Cleveland Clinic.

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Are drug studies to be trusted?

Investigators have found that pharmaceutical company sponsored drug studies are more likely to find positive results compared to government funded studies (Bourgeois FT, Murthy S, Mandl KD. Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Ann Intern Med. 2010 Aug 3;153:158-66.).

The authors couldn’t conclude whether this was good or bad. Does it mean that the drug companies inject an element of bias into their studies, or perhaps does it mean that they are more careful with their research dollars, using their funds to support studies they deem are highly likely to be successful?  Or does it mean they are doing follow up studies to expand the use of products that are known to be effective?  Are they funding studies of their drugs for conditions for which physicians have determined there seems to be efficacy?

The government studies show success much less commonly.  Is that bad?  Or does it mean government is taking on more risky studies in the hopes of finding new treatments for conditions for which there may not be good treatment?
This study does show that published drug studies by industry are more likely to show positive results, but I’m not sure we should make much of it.

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You Can’t Count on Patients to Take Their Medications — Even Me

My gerontologist has me taking generic Zocor daily to help control my cholesterol. Having obsessive-compulsive tendencies, I’m very good at taking the drug regularly. I have a seven-day pillbox that helps me remember to take the medicine as directed. But even I’m not perfect.  

A few days before my prescription ran out, I called the pharmacy for a refill. The prescription had become outdated, so the pharmacy had to contact my physician’s office for the refill. No problem. I had contacted the pharmacy several days before my pill bottle would be empty. I had four days to get the medication. 

Everything went perfectly well. The pharmacist contacted the doctor, the doctor refilled the medication, and the pharmacist prepared the prescription. Then I forgot to pick it up. I missed about three days before I realized my error.  

OK, so I missed three days. Fortunately, this isn’t the kind of medication for which missing doses can mean life or death (like HIV drug treatments or immunosuppressive drugs in someone who had an organ transplant). I rarely miss doses, realizing that if I want the drug to work, I probably need to take it.  

If a patient isn’t taking the drug exactly as directed, it isn’t the end of the world. Just be honest with your doctor about it. It’s hard enough to make a treatment plan when the doctor knows what the patient is doing. It’s that much harder when the doctor doesn’t know. 

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Copay Assistance Cards

Representatives from pharmaceutical companies are continually visiting my office bringing new, ever more generous, “copayment assistance cards” designed to make drugs more accessible.  Insurers often require patients to pay a significant share of the cost for brand name medications. These patient costs can be very high. Pharmaceutical companies are helping patients have easier access to these medications by helping pay those co-payments.

But here’s the problem. The point of the copayment is to help steer patients to lower cost alternative treatments. These copayment assistance programs not only help patients get access to expensive drugs, they eliminate the incentive to choose more cost-effective medications. Without such incentives, pharmaceutical companies don’t have to compete on price.

While I love the idea of my patients having lower cost access to drugs, I am concerned that eliminating the incentive to choose cost effective treatments is going to hurt all patients in the long run through higher drug prices.  While insurance companies are paying for those drugs, the money insurance companies use doesn’t grow on trees, it comes from patients’ pockets. It should be clear to everyone that a copayment assistant card that helps the patient “get the medication for free” doesn’t do that at all; it just means that we’re all paying for it.

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