Posts Tagged ‘drugs’

Clinical trials bring us the new wonder drugs that would have been considered either magical or miraculous in earlier times. Are you interested in how drugs are tested to assure efficacy and safety?

On two episodes of Getting Better Health Care, clinical researcher Bea Abrams, PhD, with over 30 years experience in pharmaceutical development, explains the process of clinical trials done to bring a new drug to market.  She shares with us critical information that lets us know how much we can trust new drugs and what to look out for.

In a subsequent episode, I’ll be talking with Dr. Lawrence Friedhoff — author of the book, New Drugs: An Insider’s Guide to the FDA’s New Drug Approval Process for Scientists, Investors and Patients — about myths that surround new drug development.

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Apparently there are senators from both parties seeking to remove a ban on generic drug settlements from an upcoming appropriations bill. The proposal would stop brand-name drug makers from making deals with generic manufacturers to keep generics off the market.

I’m not sure why we would need such legislation. That kind of deal sounds like the kind of collusion that should be impermissible under competition/anti-trust law.

Here are some of my other blogs on generic drugs:

It’s unfair to keep generics off the market

Pay for delay in generic drugs isn’t good for the patient

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Each day brings new joys from the electronic medical record system.  Being able to pull up graphs of patients’ laboratory results makes it so easy to assure that patients aren’t having a serious reaction to medication.  Doing refills is a snap — no more writing out prescriptions — just a couple of clicks, and it is done.  Checking for drug interactions and allergies is automatic.

And I don’t know if it is all that advantageous, but it is certainly cool to click “Send Electronically” and know that prescription will probably be ready at the pharmacy by the time the patient gets there.

We talk more about the use of electronic medical records to improve health care on my radio program, Getting Better Health Care.

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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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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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While drug companies make the innovative products that help improve and save lives, these companies also get a bad rap. Pharmaceutical companies are responsible for modern-day medications that let doctors work miracles. Is there a downside, too?

To understand the industry perspective, I spoke with Lori Reilly, Vice President for Policy and Research at the Pharmaceutical Research and Manufacturers of America (PHRMA) on Getting Better Health Care.

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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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