Academy and Retinal Specialists Meet with Genentech

The American Academy of Ophthalmology sent me this letter yesterday. Genentech has agreed to postpone its sales embargo of Avastin until January 1, 2008.

The third point below, about “Seek advanced comment,” was necessary because Genentech sent a letter to AMD patients stating that Avastin was not approved for the treatment of AMD. I was surprised when a patient called me to ask about this letter and wondered how Genentech could so easily contact patients directly? Under HIPAA privacy rules, if I want to review my own patients’ charts for research, I have to undergo a prolonged approval process with the Human Subjects Review Committee to ensure patient confidentiality.

The most significant part of this letter to me though was the paragraph that followed the bullets stating that, “Genentech reaffirmed its position that its actions were a result of communications from the FDA” and “that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.” So the FDA told Genentech or at least suggested to them that they may want to restrict Avastin sales? And if the FDA gives its clearance, then Genentech will reverse its decision?

Good. I would like retinal specialists and patients to have a choice between Avastin and Lucentis. So I’m going to write my congressmen to urge the FDA to give Genentech “sufficient clearance” to continue sales of Avastin to compounding pharmacies.

October 29, 2007

Last Friday, the leadership of the Academy and the American Society of Retina Specialists (ASRS) met with three of Genentech’s top leaders: the company’s chairman/CEO, president and chief medical officer. We had a frank and open discussion about Genentech’s decision to stop sales of Avastin® to compounding pharmacies and impressed upon them our deep concern for its impact on patients’ access to this treatment option. We are encouraged by the meeting results and hope our optimism will be justified by future actions.

Genentech has agreed to:
Delay the Avastin sales embargo to compounding pharmacies until Jan. 1, 2008, which allows us more time to help our members find work-around solutions; Not impede physicians or other legal agents (e.g., group purchasing agents) from ordering Avastin or using compounding pharmacies after the embargo is in place; Seek advance comment from the Academy and ASRS on any direct-to-patient or -physician communications on Avastin versus Lucentis®; Work with appropriate parties to make anti-VEGF therapy available for eligible low-income or under-insured patients; Ensure that an anti-VEGF agent (Avastin or Lucentis) can be made rapidly available for patients with time-critical needs in a way that minimizes in a legally appropriate manner the financial risk to the physician; and Send Susan Desmond-Hellmann, Genentech’s president of product development, to the Academy’s Retina Subspecialty Day program and the upcoming ASRS meetings, where she will discuss this issue with our membership.

Genentech reaffirmed its position that its actions were a result of communications from the FDA. The company has agreed to share the specifics of this information, which we in turn will share with our members. More importantly, however, Genentech said that it would rescind its decision if the company gets sufficient clearance to do so from the FDA.

On our part, the Academy and ASRS will continue all efforts to protect the physicians’ right and ability to use off-label drugs.

While it is hard to overlook Genentech’s initial decision, we cannot ignore the fact that the company has given ophthalmologists and patients a breakthrough treatment for macular degeneration and other eye diseases. We trust and will continue to seek verification that Genentech is committed to addressing our concerns in a reasonable and timely manner.

Sincerely,
C. Pat Wilkinson, MD, Academy President
H. Dunbar Hoskins, Jr., MD, Academy Executive Vice President
Julia Haller, MDASRS, President
American Academy of Ophthalmology
655 Beach Street San Francisco, CA 94109-1336
Tel. 866.561.8558 Fax 415.561.8533 www.aao.org

Angry at Genentech

I recently received this comment:

“Dr. Folk –
I'd like to highlight your point: "Most doctors use a dosing schedule of every four weeks for Lucentis and every six weeks for Avastin. Patients like this fifty percent increase in the time between injections."

My mother has wet ARMD in both eyes. While legally blind in one eye, the second eye was only subjected to one round of PDT damage before we switched to Avastin in Dec. 2005. She's experienced great results with Avastin.

However as with the PDT, she's one of the subset of patients that just doesn't stabilize with treatment. So for nearly 2 years, she's received injections in both eyes every 6 - 8 weeks.

The overwhelming economic argument aside, I think any policy-maker advocating a pharmacologically unwarranted change to 4 week treatment intervals vs 6 - 8 weeks should be expected to join the fun by having sham injections on the same schedule.

Then it might dawn on them that, though equivalent treatment outcomes may be realized, 50 - 100% more needle sticks HAS to increase the risk of adverse events. This is NOT like switching from once-a-day to twice-a-day dosing of an oral medication.”

This comment just reinforces the idea that I expressed earlier when I accused Genentech of practicing medicine. There are many people out there who are having great results with Avastin®. If Genentech succeeds at restricting the supply of Avastin, these people will probably have to be injected more often and this will increase the risk of side effects from the injections.

related posting: http://www.medrounds.org/amd/2007/10/genentech-pulls-plug-on-avastin.html

Who’s to Blame for High Drug Prices?

I received this comment today:

“Dr. Folk,I'm not following your logic about "Congress throwing a monkey wrench
into capitalism". It seems to me that this whole problem is Genetech's doing,
not that of any federal or government agency.”

Let me give you the short and unthoughtful answer first. Medicare will pay drug companies their asking price for new and unique drugs. If Apple had charged $4000 for the iphone, their sales would have decreased. If the iphone had been a Medicare benefit, however, Apple would have gotten the $4000. Genentech charges $2000 and they get it. Bausch & Lomb charges over $20,000 for the Retisert™ implant which is a small piece of plastic containing a tiny amount of steroid that is implanted into the eye. It is a ludicrous price but Medicare pays it which of course means that taxpayers pay for it.

The thoughtful answer though, is that Congress has sidled the FDA with a lot of new rules and regulations. The FDA demands that a drug company must prove their new drug is both safe and effective before they will approve it. Drug companies may have to spend a hundred million dollars or more to bring a drug to market and most of the drugs they develop never make it to market. The current system also delays the introduction of a new drug by years, and kills drugs that may be worthwhile but have a small market. Yes, drug companies could reduce the amount they spend on advertising or executive stock options or perks to doctors but we also want them to make enough money to keep developing new drugs. Lucentis® and Avastin® are miracle treatments for wet AMD and we should thank Genentech and their wonderful scientists.

Dr. Marianette Miller-Meeks, the Past President of the Iowa Medical Society and a practicing ophthalmologist, thinks the FDA should make sure that a drug is safe. That’s it. Safe. She thinks the market will prove whether the drug works.

This may sound risky but a drug company would be foolish to spend millions on a drug that doesn’t work. And doctors and patients would find out quickly if a drug didn’t work. There were no trials comparing Avastin with Macugen®, which was the first drug used for wet AMD. Macugen was FDA approved; Avastin wasn’t. Yet retinal doctors switched from Macugen to Avastin within weeks. Why? Because Avastin worked better. Should we have waited three or four years for the results of a clinical trial? Of course not.

We now are beginning the Comparison of AMD Treatment Trial which will compare Avastin to Lucentis in 1200 patients. This is an important trial but should the FDA wait two years for the results in these 1200 patients to give its approval when Avastin has already been used in hundreds of thousands of AMD patients world wide? Should the FDA wait even though articles documenting Avastin’s success in AMD appear almost monthly in peer reviewed journals? Of course not. The market has already shown that Avastin works.

Now we have Genentech trying to force retina doctors to use Lucentis and we have retina doctors who are very angry with Genentech. And the patient is stuck in the middle. The ophthalmology community should work with Genentech to get the FDA to fast track approval of Avastin as a treatment for AMD. Genentech can provide Avastin to ophthalmologists in a single dose vial at a reasonable charge. Genentech will still make a tidy sum. But most importantly, doctors and patients will have a choice, a choice they can make based on the best available evidence.

Genentech Pulls the Plug on Avastin®

On October 11th, Genentech wrote the retinal community that “Genentech will no longer allow compounding pharmacies to purchase this product from wholesale distributors.” The product in question is Avastin®. Susan Desmond-Hellman, the President of Product Development, stated the reason for this change was that “some” physicians were using Avastin to treat wet AMD and that “the drug had not undergone any formal, random, controlled clinical trials for ocular use.” She also state that Lucentis® was FDA approved for wet AMD. The goal of this decision is to force ophthalmologists to use Lucentis rather than Avastin for wet AMD.

The New York Times wrote that Lucentis was used in about 50% of patients with AMD which means that probably Avastin was used in the other 50%. At Iowa the trend has been back to using Avastin in lieu of Lucentis. Other ophthalmologists whom I’ve talked to are also using Avastin more and more. I suspect that Lucentis was losing market share to Avastin. Genentech, of course, make far more profit from the $2000 dollar a dose Lucentis than from the wholesale Avastin that, even after the compounding pharmacy add its charges, costs the patient around $100.

The Complications of AMD Treatment Trial will compare Lucentis to Avastin. Avastin has been used however, by thousands of retinal doctors in hundreds of thousands patients. These doctors and their patients have concluded that Avastin is a very good treatment for AMD. Most doctors can’t tell a difference between the two drugs. Most doctors use a dosing schedule of every four weeks for Lucentis and every six weeks for Avastin. Patients like this fifty percent increase in the time between injections.

The Genentech letter states that, “no patient should go without one of our approved medicines due to financial barriers alone.” The support system they mention, The LUCENTIS Commitment™ program, involves the completion of a lot of forms and costs the patient and doctor’s office hours of time. The statement implies that Genentech will pay for the drug when in reality they pay for just the part not covered by Medicare or any additional insurance. Americans pay for Lucentis either through taxes or premiums. The Wall Street Journal says that curbing Avastin could cost taxpayers $1 to $3 billion dollars a year.

Genentech is entitled to earn as much money as they can. The American taxpayer is entitled to the best medical care and the lowest price. The problem is that it is not a free market. Congress keeps throwing the wrench into capitalism and seems perfectly willing to give drug companies whatever they want at the expense of their constituents.

The real problem though is that Genentech is now practicing medicine. By restricting access to Avastin, the company is putting itself squarely between the doctor and his patient. The company is telling the doctor what drug he can use and what drug he cannot use. This is a very bad precedent. Genentech should reverse their decision.