Pay for delay is not right for generics

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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Whether it’s TSA or medicine, transparency is a good thing

NPR reports that Congressman John Mica has been pushing to replace TSA airport screening employees with screeners from private companies, and that those companies have been major contributors to Congressman Mica.  Maybe replacing TSA employees with private screeners is a good idea, maybe it isn’t.  But do we trust the opinion of a Congressman who is taking money from the companies that would benefit from this policy?  Doesn’t that money make us question his judgment on this issue?

The reason I ask has nothing to do with airport screening.  The doubt that I feel when I hear this Congressman pushing policies that help the people who give him money makes we wonder if this is how some patients feel about the advice they get from their doctor — knowing the doctor received money for services provided to drug companies.

There are growing regulations at many levels on the relationship between health care providers and drug companies.  There is also greater transparency as drug companies start reporting what they give doctors. Transparency is a good thing.

It’s too bad that when it comes to politicians, it seems we are moving in the other direction — more money and less transparency.

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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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Sometimes, you just can’t win

Sometimes, there is  not one right answer to the problems faced in medicine (or in any other field).  For example, we want drugs that have awesome efficacy.  We want drugs that are extremely safe.  We want drugs that are affordable.  It’s not likely we’ll get all three (or even two of the three) at once.

Providing the best information about prescription medications to patients is another conundrum.  As pointed out in a recent publication (Winterstein AG, Linden S, Lee AE, Fernandez EM, Kimberlin CL. Evaluation of consumer medication information dispensed in retail pharmacies. Arch Intern Med.  2010;170:1317-24), the law requires that most prescriptions be accompanied by useful written consumer medication information.

But what does “useful” mean exactly?  Putting together a “useful” handout that is readable and has the basic information is certainly going to help patients, but it is also presents a risky situation for the manufacturer.  Of course “useful” information includes material that is understandable and necessary to understand and correctly use the medication.  But should every side effect be included?  Where do you draw the line between side effects that are common and those that are too rare to include?  And if you do exclude any, how would patients feel if they developed a known rare side effect that was left out of the brochure?

National Public Radio quotes Joe Graedon — a pharmacologist, host of the People’s Pharmacy and an expert on practical drug information — as saying that there are only a few key things people really need to know about their drugs:

• how to take the drug
• the most common side effects
• symptoms to watch out for and what to do if they happen

That’s sensible advice.  However, there are many of lawyers out there — you’ve seen their ads on TV.  With so many of them around, how will people justify excluding information for patients  about even the rarest of risks, and making the brochures so long and so technical that they are no longer considered “useful?”

Note: I have been a big fan of  Graedons’ Peoples Pharmacy program for years and have been a guest on the show a few times.  You should check it out here. It is a terrific medical resource.

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More disclosure is good and nothing to fear

Major drug companies have announced plans to publicly post the payments they make to health care professionals.

I believe transparency and public candor is a good thing. Patients probably want to know if their doctor is one of those “in people” on the “cutting edge” that drug companies turn to for advice and input, as well as for presentations to physicians on what’s new in their areas of expertise.

The public probably should also know when the size of the payment is so large that it might impact a physician’s decision making.

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Understanding the drug company perspective

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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Avandia in the news

Avandia, a medicine used to treat diabetes, has been the subject of news and controversy. Concerns have been raised about the drug potentially causing an increased risk of heart attacks compared to other treatment options. An FDA panel reviewed the evidence and voted 20-12 to keep Avandia on the market.

The controversy around Avandia is complicated. Concerns were expressed that the manufacturer may have downplayed or hidden evidence of problems with the drug. But so far, a detailed examination of the evidence didn’t lead the FDA panel to call for sales of the drug to stop.

In some of the latest news about the controversy, a couple of members of the FDA panel that reviewed the drug were found to have been paid in the past for services to the company that makes Avandia or by the company that makes the competing product (Wall Street Journal). I doubt this affected the panel deliberations or decision in any substantive way.

The bottom line is that understanding the safety of drug products is really quite difficult. In the case of Avandia, it’s easy (well, at least relatively easy) to show that the drug helps patients control their sugar level. It’s much harder to know if there’s a small increased risk of heart attacks or how big that small increased risk is. If you are taking Avandia, the best course is probably to speak to your doctor about it.

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Pay for delay in generic drugs isn’t good for patients

Our health care and patent system is designed to give pharmaceutical companies strong financial incentives to develop new drugs. The system is also set up for innovative products to go generic after a time. This makes those products inexpensive. There’s concern, though, that some companies may collude to keep generics off the market. This could happen if the innovator company pays generic manufacturers not to market a product.

There’s something that just doesn’t sound right about that. Congress is working on legislation to stop the practice, and the House has approved legislation to restrict the ability of companies to enter agreements that keep generic medicines off the market. (U.S. House Approves Restrictions on Brand-Name Drug Agreements,).

Innovator companies and generic manufacturers may have disagreements on when a drug should become available as a generic. These disagreements can lead to litigation. Ideally, the solution to those disagreements shouldn’t be deals that pay off generic companies to keep generic drugs off the market.  Deals like that don’t help patients.

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