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Outrageous FDA Delay Endangers Melanoma Victims

December 2011

By Aimee Dingwell

Outrageous FDA Delay Endangers Melanoma Victims

Of the three main types of skin cancer, melanoma is by far the most dangerous. One American dies of melanoma every hour, yet it is virtually 100% curable if detected in time.1

Unfortunately, dermatologists may be missing up to 30% of curable melanomas.1

So you would think that when the FDA is presented with a completely safe, non-invasive device that can help diagnose early melanoma almost instantly, it would receive swift approval.

You would be wrong.

In this article, you will learn of the agency's ongoing and unconscionable two-year delay in approving MelaFind®, a technologically advanced optical device that boasts a 98% melanoma detection rate.

You will also discover how even as the FDA cited baseless concerns over MelaFind®'s "safety", they fast-tracked approval for a costly, mediocre melanoma drug costing $30,000 per dose with potentially lethal side effects.

You will also find out how FDA bureaucracy and bias are sending lifesaving medical innovations like MelaFind® overseas—and out of reach for most Americans.

Melanoma Detection: Methods, Flaws, and Advances

Unlike other cancers that start inside the body, melanoma begins on the skin's surface and is typically curable if caught early. But early detection is often dependent on a doctor's ability to make educated decisions on which moles they feel are necessary to biopsy.

Dermatologists consider whether or not to biopsy the hardest decision they have to make on an hourly basis.

The reason?

The average middle-aged Caucasian has 50 to 60 variously colored moles, or lesions, all over the surface of his or her body. While there may be some that squarely fit the profile of a melanoma, frequently patients present with five, ten, or more suspicious moles.

To biopsy every suspicious lesion is cost-prohibitive and leaves the patient with multiple incisions and scars for life. Yet the only way to know for sure if a suspicious skin lesion is or is not an early-stage melanoma is to do a biopsy. Dermatologists are thus confronted with critical decisions as to which lesions to biopsy.

In that decision, according to Dr. Joseph V. Gulfo, CEO of the company that developed MelaFind®, dermatologists today are missing at least 30% of curable melanomas. They also have to biopsy 50 benign lesions for every melanoma they do find. "Think about that. The value of a false positive is a minimal concern compared to missing a melanoma. Yet doctors are still missing cancerous lesions. They don't want to miss, but they are."

Contrast this with MelaFind®, a multi-spectral camera combined with sophisticated algorithms and software to image each potentially cancerous lesion. The image is then compared against a database of more than 10,000 biopsied lesions and 600 confirmed melanomas to provide the dermatologist with an immediate reading.


Each lesion is categorized as: 1) unreadable; 2) positive (biopsy); or 3) negative. According to Gulfo, study results show that the device's positive reading is associated with a detection rate of more than 98%, while the negative result is associated with a biopsy ratio of 7.6:1. This means that with MelaFind® dermatologists only have to biopsy 7.6 suspicious lesions to diagnose one melanoma. "Right now you have doctors at a 70% detection rate and up to a 50:1 biopsy rate," says Gulfo. "The number of lives saved would be impressive."

Without advanced technological devices like MelaFind®, dermatologists will continue to decide which moles should be biopsied—with the same rate of human error. This means they will have to do about 50 expensive, mutilating and time-consuming biopsies for every one melanoma diagnosed. In terms of health care cost efficiency alone, MelaFind® represents a much-needed productivity advance.

For this reason, researchers consider MelaFind® to be a lifesaving innovation, one the medical community welcomes. "I can speak for my colleagues," said Dr. Darrell Rigel, a professor of clinical dermatology at New York University. "The first response when hearing about MelaFind® is 'When is it going to be available?'"

Bureaucratic Inefficiency Blocks Innovation

While MelaFind® is safe and non-invasive, it is the first of its kind. The device is an enormous advance.

Knowing this could prompt extra interest by regulatory officials, Gulfo, who is a veteran of drug development, decided to be more aggressive than most device applications. He spent a year upfront with the FDA, meeting with the agency three times to determine the best study design and define parameters for safety and effectiveness.

The product's application received expedited review status by the FDA's Center for Devices and Radiologic Health and the company successfully entered into a binding protocol agreement, of which only about 10-12 have ever been agreed to by the FDA, noted Gulfo.

The company then conducted the largest study ever done for melanoma diagnosis. "We approached this with the discipline, the rigor, the stringency of a drug and biologic," he said. "The approval pathway is very similar to a cancer drug or biologic cancer trial. You need one pivotal trial. And that's what we did," he said.

Gulfo submitted the product for approval in June 2009, limiting its use to dermatologists. The FDA later asked Gulfo to expand the scope of the device to general physicians as well. In November 2010, an FDA panel voted 8-7 (with one abstention) to approve the diagnostic, with members objecting on grounds of safety, stating that the risk of a misdiagnosis from an "unequivocal finding" outweighed the benefit of the significant improvement in early detection. Overlooked by the FDA are the suspicious lesions that are not biopsied because of a judgment error on the part of a dermatologist.

Under the FDA's review process Advisory Panel Committee votes are used as recommendations for approval to the Commissioner.

Positive panel votes do not guarantee approval—and approval has yet to be granted by the FDA.

Citizens Petition for Lifesaving Technology

The company has since filed two amendments to the application to address the FDA's concerns with the device, including now limiting its scope to dermatologists and creating a training program, but has had no FDA response despite repeated requests for a meeting.


This silence prompted the company to file a first-ever Citizens Petition in May 2011, which legally demands current FDA Commissioner Dr. Margaret Hamburg to provide a response within 180 days. "We're inviting the commissioner to shine as big a light as possible on the review, because we want transparency," said Gulfo. "We have done everything we can to make the benefit-risk evaluation as emphatically positive as possible for the product and stop one American an hour dying from melanomas being missed. Now it is up to the FDA."

Despite all this, the MelaFind® device is still under review, some two years after submission to the FDA's Center for Devices and Radiological Health.

Ultimately the FDA claims its reasoning for withholding approval is safety.

The agency wants an additional trial to be conducted despite having previously outlined approval requirements as part of the initial protocol agreement. Certain members of the committee were concerned that a non-dermatologist would misinterpret the device's unreadable findings as an absence of disease, an assertion that Gulfo and other dermatologists find to be out of touch with how real-world medicine works and infuriating given the device was originally intended to be used only by dermatologists.

  • One American dies of melanoma every hour, yet it is 100% curable if detected in time.
  • Owing to flawed methodology, dermatologists may be missing up to 30% of curable melanomas.
  • An application was filed in June 2009 for MelaFind®, a completely safe, non-invasive device that can help diagnose early melanoma with 98% accuracy.
  • Citing concerns over "safety," the FDA is still reviewing the application for this lifesaving technology, while fast-tracking approval for ipilimumab (Yervoy™), a $30,000-per-dose, largely ineffective melanoma drug with potentially lethal side effects, including enterocolitis, hepatitis, dermatitis, and neuropathy.
  • MelaFind® was readily approved by the European Union in September 2011, while the technology languishes here in the US thanks to the FDA.
  • Reports show that FDA bureaucracy and bias are sending other lifesaving innovations like MelaFind® overseas and out of reach for most Americans.

"Their concern was that a non-dermatologist would not know what to do with unequivocal results," said Gulfo. "I do not agree with that at all. That would be like an OB/GYN saying that because a mammogram is unreadable, there is nothing to worry about. The correct response for an OB/GYN is to state 'I am sorry. I need you to come back for another mammogram or even better, obtain a far more accurate MRI of the breasts that does not emit cancer-causing radiation."