Not only high prices but short changing!

Cancer drugs can be life savers, but also budget breaking, bankrupting expenses. And the blah, blah, blah from the pharma manufactuers are that they have programs for people who can't afford them.

Herceptin is one of those life saving drugs that do not come cheap, while saving many lives of women with Her2 positive breast cancers.

Now Genentech, manufacturer of Herceptin, has been accused not once, but multiple times of short changing hospitals in the amount of drugs provided. Of course, they are denying the claim. But since it didn't happen just once, I have very suspicious.

I try not to be cynical but when something happens more than once, it becomes a duck (walks like, talks like, etc.).

An ounce of prevention is worth of pound of cure

So the FDA has acted (the ounce). Yes they work slowly but personally I prefer they do that and not rush drugs through the approval process. (Something about deadly

But I digress. Because of that evil man who jacked up the price of a drug because he could and didn't care about the patients, the FDA has moved to see if they can expedite reviews of certain generic drugs (the pound).

"The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold."

I like this idea. A lot. Since a generic is essentially the same (but not quite exactly) of existing patented medications, the approval process is much easier than for brand new drugs (or so I believe). The problem is the agency has a backlog of generic medication applications. So now they will see if they can speed some up.

The more generics available, the better. This makes me happy. 

Doctors Paid to Tweet

Twice last year (March and June) I blogged about doctors who provide medical advice in a tweet. Now I found out that doctors are being paid by pharma companies to tweet about specific medications. And doctors who use social media do not disclose that they have been paid to do so.

So now I am even more on the side of medical advice for me will not come for a tweet. Their impact on my life will be the same as an ad for a pharma product - I ignore them and wait until my doctor tells me about it.

Heck yeah

Are we ready for pharmaceutical company price wars? Heck yeah! There has been a lot of 'hoohah' going on pricing with pharmaceutical companies, especially for Gilead's hepatitis C drugs which came in at a shocking $84,000 per treatment course. Which was later upped to $90K plus for second treatment option.

Now Merck has stepped into the hep C market with a new drug which is only a paltry $54,600 treatment for a 12 week course of treatment. Wowza!!! That's so much more affordable.

Of course Gilead says Merck's treatment isn't as good (of course). [And their CEO just stepped down because of the pricing crisis.] But the stock analysts are rooting for Merck on this one so we will just have to wait and see who wins this one.

But maybe instead of focusing on the big companies we should talk about the benefits to the patients. But the big news:

"One industry consultant, Roger Longman of Read Endpoints, a research firm that tracks reimbursement issues, believes that Merck’s pricing may be sufficiently tempting for benefits managers. That’s because its new treatment carries a lower list price than the Harvoni list prices, regardless of whether patients take that treatment for eight or 12 weeks, depending upon their strain of the virus.

“Essentially, what Merck has done is undercut Harvoni” in most patient populations, he explained. “And remember that Merck will also offer rebates. So they’re giving themselves some room to make it still more attractive for pharmacy benefits managers, some of which may have contracts that allow them to switch drugs if there’s a dramatic price difference from a new product.”"

So maybe there is hope for the patients after all.

21st Century Cures Act

This is a looming problem as the pharmaceutical industry lobbies its way through Congress. The Act would enable the pharma industry to postpone longer availability of generics, allow fewer safeguards for new drug development which will supposedly enable faster cures. But would do nothing to stop even higher prices on new drugs.

" Rather than simply charging less, the industry is pushing for watered-down safeguards it claims will lower development costs and get patented drugs to market sooner and cheaper. It will deploy 1,200 lobbyists to try to pass the 21st Century Cures Act. This bill has already passed the U.S. House of Representatives and will have its companion bill introduced in the Senate."

"This initiative is being sold as enabling new cures to treat rare and difficult-to-treat diseases by increasing funding for biomedical research at the National Institutes of Health. But, at the same time, the pharmaceutical industry will be able to use this bill to undermine FDA safety requirements by making it easier to get their drugs approved more quickly. The industry blames rising drug development costs on the FDA's drug approval process, which it says is too lengthy."

The FDA is not there to slow approvals but to keep American's safe. Using Vioxx as an example, this drug was approved and then found to cause thousands of heart attacks and deaths. 

"Investing in scientific research is, of course, a no-brainer. But the Cures Act will not only do that. Under the bill, research funding would be increased at the expense of lowering patient protections and reducing access for affordable medicines.

A key responsibility of the FDA is oversight to ensure that the risks of new drugs and medical devices don't outweigh the benefits.

Well-designed Phase III clinical trials conducted by pharmaceutical companies to get their drugs approved by the FDA are critical for weeding out unsafe and ineffective drugs. More than a third of the drugs that enter Phase III testing fail to gain FDA approval for this reason.

One of the main advocates behind the 21st Century Cures Act, The Manhattan Institute, cites drug development costs of Phase III clinical trials as a barrier to medical innovation and rising costs."

But the problem isn't with the FDA approval process. Its that 1/3 of the drugs going through Phase III trials fail because the drugs don't work. Where is the patient safety if the drug doesn't work or has too any side effects?

"...the pharmaceutical industry will make exaggerated claims and call for reforms gutting safeguards in the name of reducing drug prices. It will contest how its products save lives, extolling the virtues of their government-backed monopoly pricing power that in reality exploits our poor and sick. The 21st Century Cures Act will be included in this campaign."

He's walking the walk, not just talking the talk

Here's an example of someone who is really walking the walk. A former NHL (Non Hodgkin Lymphoma) patient, Robert Bazemore, is now the CEO of Epizyme which is developing a drug targetting NHL (which is not just a hockey league for some with cancer).

This is huge to me.  I greatly hope that this means the company will focus on the patients and not just on the bottom line.  The article mentions that he did not mention his medical history when interviewing for the board but did reveal it after learning about the focus of the company.

As a cancer person it is very difficult not to let a disease define you and what you do. Often we keep it hidden from co-workers because we do not want to be labeled or thought of as being sick. This can be a huge detriment to one's career path. If others think we aren't physically up to a job or we might n need too much time off and would be a burden to the company and therefore would not get a job offer.

But now that we have a CEO, openly a cancer person, running a company which is developing a drug that might help him and others with his same cancer. I am a huge fan.

I wish more people could do this and society would not shame people for medical issues.